MX2011000316A

MX2011000316A - Peritoneal equilibration test and dialysis system using same.

Info

Publication number: MX2011000316A
Application number: MX2011000316A
Authority: MX
Inventors: Robert W Childers; Anping Yu; Edward F Vonesh; Benjamin Kellam; Borut Cizman
Original assignee: Baxter Int
Priority date: 2008-07-09
Filing date: 2009-07-09
Publication date: 2011-03-01
Also published as: JP5534362B2; WO2010006147A1; JP2011527619A; US20100010425A1; EP2340069B1; US9147045B2; JP2014168696A; JP5936207B2; EP2340069A1

Abstract

An ultrafiltration ("UF") evaluation method includes: (i) determining an amount of UF removed from a patient over a first dwell time; (ii) determine an amount of UF removed from the patient over a second, different dwell time; (iii) determining an amount of UF removed from the patient over a third, different dwell time; and (iv) fitting a curve to the UF removal amounts for the first, second and third dwell time. A peritoneal dialysis therapy generation method using the curve determined according to the "UF" evaluation method to generate at least one peritoneal dialysis therapy regimen.

Description

PERITONEAL EQUILIBRIUM TEST AND SYSTEMS OF DIALYSIS USING THE SAME Background of the Invention The proportion of patients performing automatic peritoneal dialysis ("APD") is increasing worldwide, which is partly due to the ability of the APD to be adapted to the particular needs of a patient, with respect to the needs of your private life and the needs of your therapy in particular. The two main goals of dialysis, clearance and ultrafiltration of solutes ("UF") depends on the type or type of APD that is performed (eg, peritoneal intermittent nocturnal dialysis ("NIPD"), peritoneal recycling dialysis continuous ("CCPD") and CCPD of high dose, type of solution, time of therapy and filling volume.To prescribe an APD therapy is to select one of these, therefore there are many combinations and possibilities of which one can to choose.

APD devices usually do not have the ability to provide feedback to the patient, regarding the effectiveness of their recent therapies. Likewise, APD devices normally run an open circuit, so that they do not adjust the therapy parameters (for example, modality, type of solution, therapy time and filling volume) based on the actual measured daily UF and clearance. Therefore, I some patients do not fully achieve their goals and develop adverse conditions, such as overloading fjuidos and in some cases, hypertension. The current methods to adjust the treatment usually imply that the patient frequently reports to a center to be evaluated. These methods impose the burden of adjusting the therapy only in the doctor or specialist and patients do not go often enough to adjust therapy appropriately to change the lifestyle of the patient on a weekly, monthly, seasonal or other.

The systems and methods of the present disclosure attempt to remedy the above problems.

Brief Description of the Invention The system of the present disclosure includes a plurality of prescription optimization modules. One of the modules is an advanced peritoneal balance test (or "PET"). PET allows the patient to perform part of the ultrafiltration ("UF") of the PET at home automatically using his automatic peritoneal dialysis machine ("APD"). The automatic test collects simpler UF data points than in the past, which helps to establish a more accurate UF patient-characteristic curve. Subsequently, the work of the UF samples and the blood is used to generate physiological data of the patient.

A second module of the prescription optimization system of the present disclosure is to use the above physiological data of the patient to continue the therapy objectives (for example UF, clearance) and the specific ranges of therapy inputs (e.g. number of exchanges, recycling times, solution choices) to calculate or supply all possible regimes that fit within the ranges provided.

A third aspect or module of the present disclosure is to use one or more filters that specify a patient's preference or the doctor's performance requirement, to decrease the number of regimens to a smaller number that is manageable. The agreement of the doctor or patient in a certain number of regimens, for example, three to five regimens, will be prescribed by the doctor for treatment.

Another feature of the present description is an inventory tracking module that tracks the different solutions and other supplies used in a supply cycle to carry out the different prescriptions selected by the patient. The APD machine has the ability to mix dialysis solutions of different levels of dextrose to produce hybrid dextrose dialysate combinations, which also allows the patient's treatment to be optimized. The records of the inventory tracking feature records dextrose levels and replaces the associated dialysate concentrations consumed.

A fifth module of the present description is a trend of the prescriptions that patients are carrying out. Trends can track any of one or more of the FUs removed, body weight, blood pressure and prescription used. A sixth module controls how different prescriptions are reused and adjusted or replaced as necessary. Trends can also show averages, such as an average UF in a 7-day movement and / or a 30-day moving average.

In one modality, the patient at the beginning of the treatment is weighed also (ie after the initial drainage) and takes his blood pressure. As described in detail below, the system of the present invention includes a scale and an apparatus for taking the pressure that wirelessly produces to the APD machine the information of weight and blood pressure, respectively, using wireless technology such as technology. Bluetooth ™, WiFi ™, Zigbee ™. The wireless link is provided through radiofrequency transmission in one modality. In an alternative embodiment, the weight and blood pressure information is provided through a wired connection between the scale and the blood pressure machine and the APD machine. The patient alternately types in the weight and blood data.

The APD machine provides multiple therapy prescriptions from which either the patient or the APD machine choose to treat that day. For example, the APD machine can provide five approved prescriptions for the patient, one of which is chosen based on the weight, blood pressure and UF of the patient and eliminated during the last 24 hours. The prescription does not need to be selected before the initial drainage (initial drainage is performed in any of the possible treatments) so that the patient or machine can obtain the final UF information from the treatment of the previous day before determining which prescription is to be selected. The machine in a modality provides warnings at the beginning of the treatment to remind the patient to obtain his weight and blood pressure data.

The five possible prescriptions are determined analytically. One possibility is to develop and store an algorithm either on the APD machine itself or on a server computer that communicates with the APD machine, for example through an internet connection. The algorithm can employ a three-pore model, for example, which adds anticipated clearance through three different pore sizes in the patient's peritoneal membrane. The flow of toxins through the large pores, small pores and micropores in the blood vessels of the peritoneal membrane, add up. For example, urea and creatinine are removed from the patient's blood through small pores. Large pores allow larger protein molecules from the patient's blood to pass into the dialysate. In each case, an osmotic gradient carries the toxins from the patient's blood to the dialysate. Using the anticipated clearance and the three-pore model, the system of the present disclosure produces a plurality of regimens acceptable to the patient. Of these regimes, you can select, for example, five prescriptions. The algorithm alternatively uses a two-set model, as described in detail below.

In one embodiment, the system-generating part of the system is stored and used in a dialysis center or nephrologist's office. The patient enters the office or center, and the doctor or specialist reviews the patient, enters the patient's data in the generation software located in the office or center, which produces the appropriate regimens of which, for example five Different prescriptions will be selected. It is expected that these different prescriptions address the patient's diverse ADP needs for the foreseeable future, for example, in the next six months up to one year. New patients may have residual kidney function ("RRF"), so that their kidneys are partially functional. These patients do not need treatments as aggressive as those of a patient without renal function. However, the need for adjustment for these patients may be greater as RRF degrades. Here, the plurality of prescriptions may need to be updated more frequently, even every three months.

The three-pore model is very good for anticipating clearance values, such as urea removed, Kt / V, pKt / V, eliminated creatinine, CCr, pCCr, glucose uptake and total effluent. The system of the present disclosure also utilizes an advanced peritoneal effectiveness ("PET") test to help accurately anticipate UF elimination. Advanced PET also includes blood samples and chemical analyzes carried out on dialysate samples, to accurately anticipate patient clearance for eliminated urea, Kt / V, pKt / v, eliminated creatinine, CCr, pCCr, absorption of glucose and total effluent, even better.

With respect to the advanced PET module of the present invention, advanced PET include samples that are taken in two therapies. In the first therapy, for example, UF is measured after a retention of 30 minutes, retention of 60 minutes, retention of 120 minutes and retention of 240 minutes, giving as a total 7.5 hours. In the second therapy, UF is measured after a retention time of 8 hours, providing a total of five data points. At each time interval, the patient is drained completely to accurately determine the UF. The UF can be measured through the APD machine or as an alternative or additionally through a weight scale, if more precision is desired. Because the patient has to refill each time after draining completely, the actual UF time periods may differ slightly from the projected UF time periods. For example, the UF time period of 2 hours can actually take 2 hours and 10 minutes. The system of the present invention records the real time period, and uses real time as an input to the kinetic modeling.

Blood and dialysate samples can be taken at certain intervals whenever and wherever the blood is drawn. The first and second therapies should be carried out consecutively or for two nights. In one modality, the patient carries out the night before being in bed, the fillings / retentions / drains of half an hour, 1 hour and 4 hours. The patient then carries out the last filling, falls asleep and wakes up when carrying out the 8-hour drain. UF and the actual retention times are recorded for each retention period. The data can be recorded on a data card that the patient presents the next day in the laboratory or center. The data is transferred to the laboratory or center in an alternative way through an internet network using the data communication module described here.

The patient subsequently travels to the dialysis center. The patient is filled for an additional time. Blood and dialysate samples are taken in 2 hours and 4 hours, for example. A second UF drain data point of 4 hours can be taken and compared to the first UF drain data point of 4 hours for additional accuracy.

For the five UF data points, blood test data and dialysate tests are obtained using a particular dialysate concentrate, such as 2.5% dextrose. The data points generate data of mass transfer area coefficient ("MTAC") and hydraulic permeability data to classify the transport characteristics and UF of the patient, which will subsequently be applied physiologically to other types of dialysate concentrate, such as dextrose at 1.5% and dialyzed Extraneal®.

With respect to the regime generation module of the present description, the > Prediction algorithms use previously calculated patient transport and UF characteristics, objective information and other input information to therapy to generate the regimes. The objective information and other information of the therapy includes for example: (i) clinical objectives such as (a) minimum urea clearance, (b) minimal urea Kt / V, (c) minimal creatinine clearance, (d) absorption of maximum glucose and (e) target UF; and (ii) therapy parameters such as (a) therapy time, (b) therapy volume, (c) filling volume, (d) percentage of dextrose, and (e) type of solution; and (iii) available solutions. Many of these entries are expressed in ranges, leading to many possible regime outcomes. The software that uses the equations of the three-pore model and two combinations generates, in one modality, each possible regime using (i) each entry in each range and (ii) the characteristics of UF and patient transport, which complies with the objective and therapy information described above.

With respect to the filtering prescription module, the system allows the user to specify certain filtering information to match regime combinations with a manageable number of combinations of which is selected and approved as a set of prescriptions. The filtering information may include for example filtering all regimens with aKt / V, creatinine clearance and UF below a certain value, and glucose absorbed before a certain value. The specialist and the patient subsequently agree on a few of the prescription options paired downwards to be stored as prescriptions on the patient's ADP machine, or alternatively, on a server computer that has a communications link with the APD machine.

The prescriptions can be stored on the patient's data card and physically loaded on the APD machine when the patient returns home. As an alternative, a dialysis center discharges the requirements to the APD machine through an internet network or other data communication network. A set of prescriptions may include, for example: (i) a standard UF prescription; (ii) a high-level UF prescription; and (iii) a low level UF prescription. If the patient has the capacity, the APD system can be adjusted to allow him to administer a prescription tailored to the day's activities. If the patient exercises strongly on certain days, large amounts of body fluids may be released through sweat, the patient may administer a lower level UF treatment that night, possibly saving the patient from having to carry out an exchange of medication. day the next day. If the patient is out at a dinner on a certain night and consumes more fluids than usual, the patient can administer the high-level UF treatment. On all other days, the patient administers the standard UF prescription.

A corollary component of the system of the present invention is the inventory tracking and distribution module. If the selected prescriptions require different types of dialysate concentrates, the different dialysate types need to be supplied in the correct amount. In the system of the present invention, either the APD machine or the specialist server, it tracks the current patient inventory, and ensures that the necessary supply of adequate solutions is delivered to the patient's home.

As described in the present invention, one of the parameters of the therapy is the percentage of dextrose in the solution, which affects the amount of UF removed and the amount of calories absorbed by the patient. More dextrose results in more UF removed, which is generally desirable. However, more dextrose results in more caloric intake and weight gain in the patient, which is not desirable. The dextrose profile is therefore an important factor in selecting the patient's possible therapies. The different solutions are provided in different percentages of dextrose, such as 1.5%, 2.5% and 4.25% dextrose. The APD machine described in connection with the system of the present invention has the ability to connect to multiple solution bags having different percentages of glucose and extract solution from different bags to form a mixed or combined solution, for example, in a bag more warm or in the peritoneum of the patient and an on-line heating is used, which has a desired percentage of glucose different from the percentages evaluated, for example 2.0%, 2.88%, 3.38% and 3.81% dextrose. If mixed in a more tempered bag, the warmer bag can be fitted with one or more conductive strips, which allows a temperature-compensated conductivity reading of the mixed solution to be taken to ensure that the solutions have been mixed in a adequate In one embodiment, the APD machine tracks the different bags used during the treatment during the course of a supply cycle. Before the person arrives with new solution bags, the inventory used is sent to the solution distribution facility. This inventory is subtracted from the patient's total household inventory, so that the solution distribution facility knows how much of which solution (s) to supply to the patient's home. In one modality, when the supply person arrives at the patient's home, the supply person scans the patient's remaining inventory to compare with what is expected to still remain. The APD machine does not automatically count the solution bags that will be destroyed, lost or otherwise not used for treatment. However, it is contemplated that a number of lost or destroyed bags (or the actual total number of bags still remaining) will be allowed to enter the patient in the APD machine tracking system, if it is discovered that said procedure provides information on more accurate advance inventory. The exploration by the person supplying the remaining product in any case, readjusts the patient's inventory in each supply, so that the errors are not cumulative.

With respect to the trend generation and warning module, the APD system of the present invention tracks and develops trends of certain parameters of the therapy, such as daily UF, blood pressure and body weight. Trends in a modality can be appreciated in the APD machine deployment apparatus between therapies, for example at the beginning of a therapy. The trends can also be seen by the specialist and / or doctor. The patient at the beginning of the therapy can see for example the weight, blood pressure and UF of the patient eliminated in the last 24 hours. The patient can learn from the FU of the previous day, after the initial draining of the patient, which comes from the last filling of the previous night's therapy. That is, at the end of a first initial drainage until the end of the second initial drainage, a UF cycle is adjusted that is recorded. The patient, after the initial drainage, is also weighed, providing data that are entered into the machine through wired or wireless devices, or alternatively, through patient input. Trend data in combination with the adjustment of filters or criteria are used either to allow the treatment to be carried out under a normal set of prescriptions or to be administered through a new prescription (s). The machine in a mode automatically alerts the specialist if an alarm condition occurs or if a prescription change is needed.

Trend screens, for example, can show a daily UF trend, an average trend in a 7 day movement and an average trend in a 30 day movement. Average movement trends smooth daily highs and lows and more easily indicate the UF up and down trends. When the actual UF removed falls below a low threshold value of UF removed, for example, during a previously defined time period, or in combination with the patient's administration of a high level UF prescription to avoid a UF underperformance, the The system of the present invention causes the APD machine to send an alarm or warning signal to the dialysis center and / or doctor. In the present invention, different methods or algorithms are described to prevent the system from overreacting or being too sensitive. In addition to enrolling the UF averages, the system also uses algorithms that accumulate errors and look for other physiological parameters of the patient, such as weight and blood pressure in an attempt to see the patient in a more general way, instead of just observing a UF elimination. .

With regard to the adjustment module and prescription repetition, the specialist or doctor responds to the prescription alarm in an appropriate manner, such as calling the patient to the clinic, making suggestions via telephone or email regarding the use of prescriptions. currently existing, ordering a new PET, and / or changing the patient's prescriptions. The system is configured in this way to eliminate the burden of detecting a defective performance prescription (s) by the specialist or doctor, and to alert of such defective performance prescription as soon as reasonably possible, without overreacting one or more sub-performers in the day.

If an alert condition occurs and the APD machine does not have the ability to communicate the alert condition to the specialist or center, for example, the internet service is not available or accessible, the system is configured to have a warning from the APD machine for the patient to contact the specialist or center. For this purpose, the system includes a communication protocol procedure in which the specialist server sends an electronic reception message confirmed to the APD machine, so that the APD knows that the alert has been received.

The APD system can be adjusted to respond in a closed circuit manner to a consistent sub-performance therapy. Here, the APD machine stores a database of acceptable prescriptions, for example, the five prescriptions prescribed previously by the doctor. The machine automatically selects a prescription approved by the doctor in an attempt to improve the results. For example, the machine may select a higher UF prescription if the patient's UF has been performed with a sub-performance. Or, the machine presents a number of prescription options to the patient, who selects one or more prescription approvals from the doctor. It will be appreciated that in one modality, the system only allows the patient to administer an approved prescription by a doctor.

In another alternative embodiment, the plurality of, for example, five approved prescriptions, are loaded into the patient's APD machine but only one subgroup is allowed, for example, three out of five prescriptions. When it is found that the habilitated treatments will be carried out with a sub-performance, a doctor or specialist allows a therapy not previously enabled, that is, for example, with the ability to increase the UF of the patient. In this way, the doctor or specialist can select from a set of pre-approved prescriptions and not have to re-administer the prescription sequence prescription and filtration prescription described above. The system can also provide the aforementioned alert responses for blood pressure and body weight alert conditions.

The system can respond to alerts in other ways in addition to changing the patient's prescription. The trends show in which days the prescriptions have been administered, so that the doctor or specialist can see if the patient is administering the sufficient therapies and / or the correct therapies. The trends also show the weight of the patient, which allows the doctor or specialist to recommend the patient to reduce their intake of food and drinks, if the patient has gained too much weight. The patient's blood pressure may also have a tendency and be considered in an alert. Here a plurality of algorithms and examples illustrating the possible repercussions of a patient alert are described.

When the patient's therapy is functioning properly, the system can operate to allow the patient to select to administer a prescription on a given day. The machine or system can alternatively select the daily prescriptions that must be administered, or some combinations thereof. Here a number of algorithms or prescription adjustment methods are described, which attempt to balance the patient's flexibility and lifestyle aspects with the performance aspects of the therapy.

Accordingly, it is an advantage of the present disclosure to provide an APD system that analyzes the patient's treatment data and communicates the results to the doctor or specialist, who may subsequently spend more time talking to the patient, rather than carrying out the analysis. in a manual way It is another advantage of the present disclosure to provide a peritoneal dialysis system that attempts to optimize a therapy prescription for the patient.

Still further, it is an advantage of the system of the present disclosure to follow up on or develop trends of the various PD physiological parameters of the patient, to provide enrollment averages thereof, and to react quickly, but not overreact, to an apparent underperformance of the patient. the therapy.

It is a further advantage of the system of the present disclosure to provide a closed-circuit PD system that responds to UF under-performance, weight gain and / or high blood pressure of the patient.

It is still another advantage of the system of the present disclosure to provide a tracking system for the use of the patient's solution to efficiently deliver multiple solutions necessary to the patient.

It is still an additional advantage of the system of the present disclosure to provide a dialysis system that mixes the standard dextrose solutions to achieve a desired combined dextrose level dialysate.

It is still an additional advantage of the system of the present disclosure to provide a dialysis system having a plurality of approved prescriptions from which the patient can choose to adapt to the daily needs thereof.

It is yet another advantage of the system of the present disclosure to provide a dialysis system that uses a more accurate peritoneal balance test.

In the present invention, additional features and advantages are described, and may be appreciated from the Detailed Description and from the figures that follow.

Brief Description of the Figures Figure 1 is a schematic view of one embodiment of the prescription optimization system of the present disclosure, which includes an improved peritoneal equilibrium ("PET") test module, a rate generation module, a filtration module, and prescription selection, a dialysis fluid inventory management module, a communications module, a data entry module, a trend generation and alerting module, and a prescription adjustment and repetition module.

Figure 2A is a perspective view of a peritoneal blood vessel showing the different pore sizes used in a three-pore model to anticipate the results of peritoneal dialysis therapy.

Figure 2B is a schematic view of the kinetic transport properties of a two-combination model used to anticipate the results of peritoneal dialysis therapy.

Figure 3 illustrates a trace of UF sample removed versus retention time of the data collected by the home dialysis instrument, for use with an improved peritoneal balance ("PET") test of the present disclosure.

Figures 4A to 4D are sample screens displayed on the computer of the specialist or doctor as part of the system of the present disclosure, which illustrates additional data associated with the improved PET module.

Figure 5 is a sample screen displayed on the computer of the specialist or doctor as part of the system of the present description, which illustrates the data associated with the regime generation module.

Figures 6A to 6C are sample screens displayed on the computer of the specialist or doctor as part of the system of the present description, which illustrates the filtering criteria used to filter the regimens generated in possible prescriptions for therapy.

Figures 7A and 7B are sample screens displayed on the computer of the specialist or doctor as part of the system of the present description, which illustrate the selection of prescriptions from the list of filtered regimens.

Figures 8A to 8C are sample screens displayed on the computer of the specialist or doctor as part of the system of the present description, which illustrate what is agreed upon in the prescriptions of high level UF, standard UF and low level UF, respectively.

Figures 9A to 9E illustrate another example of a filtration process according to the present disclosure, which results in a final filter of three regimens prescribed for the patient.

Figures 10 to 13 are sample screens displayed on the computer of the specialist or doctor as part of the system of the present description, which illustrate one embodiment of an inventory management module.

Fig. 14 is a perspective view of one embodiment of a dialysis instrument and a disposable pump cartridge illustrating an apparatus suitable for carrying out the dextrose mixing used with the prescription optimization system of the present disclosure.

Figures 15A and 15B are schematic views illustrating modalities of wireless and wired communication modules, respectively, for the prescription optimization system of the present disclosure.

Figure 16A is a schematic view illustrating another embodiment of a communication module and mode for the data collection module, including the wireless input of weight and blood pressure data for the prescription optimization system of the present description.

Figure 16B is a schematic view illustrating a further embodiment of a communication module, in which a central clinical server is located in or associated with a particular dialysis center.

Figures 17 to 21 are sample screens displayed on a patient's dialysis instrument, illustrating various trend data available to the patient.

Figures 22 and 23 are screens of samples displayed on the dialysis instrument of a patient or on a computer of a specialist and / or doctor, as part of the trend module of the present description, which illustrates various trend data including averages of UF movement, target UF, daily UF, UF limits and prescription used.

Figure 24 is a schematic diagram illustrating a possible alert generation algorithm for the trend generation and warning module of the prescription optimization system of the present disclosure.

Figure 25 is a logical flow diagram illustrating another possible alert / prescription generation modification algorithm for the trend and alert generation module of the prescription optimization system of the present disclosure.

Figure 26 is a sample screen displayed on the dialysis instrument of a patient or a computer of a specialist and / or doctor as part of the system of the present disclosure, illustrating various trend data including averages of UF movement and UF limits determined by statistical process control.

Figure 27 is a sample screen displayed on the dialysis instrument of a patient or on the computer of a specialist and / or doctor as part of the system of the present disclosure, illustrating various trend data including UF movement averages. , UF objective, prescription used and UF limits determined through statistical process control.

Fig. 28 is a schematic view of a mode of a transfer function used for the prescription adjustment and repetition module of the prescription optimization system of the present disclosure.

Figure 29 is a sample screen displayed on the dialysis instrument of a patient, illustrating a possible repetition mode of prescription of the adjustment and prescription repetition module of the prescription optimization system of the present disclosure.

Detailed description of the invention Referring now to the drawings and in particular to Figure 1, a schematic view of a peritoneal dialysis system ("PD") 10 having an automatic peritoneal dialysis machine ("APD") 104 is illustrated. System 10 provides and uses an improved peritoneal equilibrium ("PET") test 12, which shows and employs multiple data points to determine the ultrafiltration curve ("UF") of the patient during the course of treatment. PET 12 improves the UF prediction used to characterize an individual's response to PD therapies, and helps the specialist generate prescriptions optimized for patients. In one embodiment, PET 12 is carried out as a fixed therapy using the APD 104 machine found in the home. PET 12 also requires laboratory tests and analysis, as set forth below.

The system 10 also carries out a generation of automatic regimen 14. A generation of a known regimen is carried out manually by a specialist 110 or doctor 120 using a success or error type strategy, which is delayed and depends on the scientific rationing by the nurse or specialist. The generation characteristic of automatic regimen 14 uses the results of PET 12, the input parameters of the therapy and the objective parameters of the therapy entered to generate the regimens for the specialist 110 or medical 120, which save time and increase the probability of that one or more regimens that meet the goals of therapy for clearance and UF are generated, minimizes glucose exposure and meets lifestyle needs.

The system 10 further includes a prescription filtering module 16, which reduces the various regimes generated by the automatic regimen generation feature 14 to a manageable number of prescriptions, which are subsequently selected by the patient and doctor / specialist to provide a set of approved prescriptions that are loaded on the patient's APD 104 machine at home. In one embodiment, the APD 104 machine supports up to five prescriptions that are transferred to the APD 104 machine through a data card, the internet or another type of data communication. Different prescriptions may include, for example, two primary (or standard) prescriptions, one volume-depleted prescription (low-level UF) and two 'fluid-overloaded prescriptions (high-level UF), giving a total of five. Not all prescriptions have to be enabled by the specialist. However, once they are enabled by the specialist, the multiple prescriptions provide flexibility to the patient and allow the APD 104 machine and therapy to better suit the needs of the patient's lifestyle, still providing adequate therapy.

The filtration requirement 16 naturally leads to an inventory tracking feature or module 18. Different prescriptions may require the patient to store different types of PD solutions in their home. For example, one type of solution can be used for overnight exchanges, while a second type of solution is used for the last fill or exchange of the day. Likewise, the same type of solution can be provided in different amounts of dextrose. The system 10 determines what kinds and varieties of types of solutions are needed, quantities of such types and varieties and what related disposable components are necessary to carry out the prescribed requirements. The APD 104 machine tracks how many solutions and what type and variety are used during the course of a supply cycle, and communicates the use to the specialist server. Subsequently the specialist's server determines how much and from what supplies need to be administered to the patient for the next supply cycle. When the supply person arrives at the patient's house, you can scan the patient's actual remaining inventory to compare it against the remaining inventory expected by the specialist's server. If necessary, the patient's supply can be adjusted. Here, the post-supply inventory of the patient is known and sent to the specialist's server. Communication is carried out using a communication module, which is described later.

The system 10, as mentioned, includes a therapy data upload and prescription download communication module 20 that transfers the data between the APD software and the doctor / specialist software, for example, through any of one or More of the internet, modem and cell phone. The dialysis center can use the communication module 20 for example to send the loaded prescriptions to the patient's APD machine. The therapy data, the records, the trend data can be uploaded to the doctor / specialist data center, so that the specialist or doctor can access the patient's information at any time and from any place The system 10 also includes an automatic data collection feature of, for example, body weight and blood pressure, UF 24 hours. The APD machine determines the 24-hour UF of the patient and obtains blood pressure and body weight in a daily and automatic way. A remote exchange system ("RES") collects the patient's half-day exchange data and feeds said data daily to the APD machine, for example, via bluetooth or other wireless communication. Blood pressure and body weight devices also communicate the patient's blood pressure and body weight to the APD machine, for example on a daily basis and wirelessly. The data collection feature 22 also includes the collection and entry ranges of the target information therapy, for example, in the regime generation characteristic 14.

The system 10 also includes a trend generation and alert feature 24. The APD machine provides, for example, up to 90 days of trend generation of 24-hour UF, blood pressure, heart rate, body weight and prescription used. The patient, the specialist and / or doctor can see these curves on the screen of the APD machine, the specialist's computer or the doctor's computer. The APD machine obtains the necessary data for the trends, sends the data to a server computer, which in turn generates and monitors trends. The APD machine and / or specialist software monitors the patient's therapy trend data and generates alerts when any of the vital parameters fall outside the preset range of a specialist (or out of range in combination with other filtering criteria) of alert described here).

The system 10 further includes a feature of repetition and modification of prescription 26. Based on the data coming from the trend feature 24, the patient 102, the doctor 110 and / or the dialysis center 120, a prescription can be repeated approved for daily use with respect to another. For example, if the patient's UF results of the latter days are less than expected, patient 102, doctor 110 and / or dialysis center 120 may decide to use a higher UF prescription in the opposite way to a standard UF prescription. System 10, for example, can store three or five different prescriptions, all of which have been approved by the doctor. The five prescriptions may include, for example, (i) low level UF, (ii) standard UF with a shorter duration and higher dextrose content, (iii) standard UF with longer duration and lower dextrose content, (iv) High level UF with shorter duration and higher dextrose content and (v) higher UF with longer duration and lower dextrose content.

If the patient 102, the doctor 110 and / or the dialysis center 120 know that the patient has gained weight of the latter, you can select a prescription with lower dextrose content to reduce caloric intake by treatment. Otherwise the patient may wish to administer a shorter therapy or one without a half-day exchange for lifestyle reasons. The system 10 can be configured so that the patient chooses which prescription to administer on a given day. As an alternative, the dialysis instrument 104 administers a prescription discharged from the dialysis center 120. In addition, alternatively, the dialysis instrument 104 administers a prescription discharged from the doctor 110. The system 10 can administer a hybrid control, which for example allows the patient choose which prescription to administer on a given day, provided that the patient is making responsible choices, and if the patient does not take responsible choices, the system 10 is switched so that the administration prescription for the patient is adjusted by the machine. Alternatively, if the patient does not make responsible choices, the system 10 can, for example, eliminate less aggressive options from the list of possible prescriptions, and still allow the patient to choose from the remaining prescriptions.

Many PD patients lose residual kidney function ("RRF") over time, so PD therapy needs to eliminate more UF. Also, the patient's transport characteristics may decrease due to the loss of RRF. When the trend function 24 indicates that the patient's FU is underperforming, it does not matter which prescription the patient is administering, the patient is gaining too much weight, the patient's blood pressure is too high or a combination of these conditions occurs, the system 10 according to module 26 will automatically alert that the prescriptions of the patient probably need to be modified. Here, a number of measures are described which are taken so that the system 10 is not oversensitive and allows natural fluctuations in the patient's FU, due for example to an error of the instrument and to the residual volume of fluid left in the patient's peritoneum. However, when the patient shows a sufficient underdevelopment pattern to indicate that it is not the result of a normal fluctuation, the system 10 institutes a number of procedures to improve the PD performance of the patient. For example, the system 10 can request that a new PET be carried out, that new regimes be generated correspondingly, and that new prescriptions from the regimes generated be filtered. Or, possibly, as an initial attempt, the system 10 asks for a new set of filtering criteria (for example, stricter therapy criteria) to be applied to previously generated regimes to filter a new set of prescriptions. The new prescriptions are downloaded to the patient's dialysis instrument 104 through either a data memory card or through an internet link from the doctor's office 110 or the dialysis clinic 120.

Peritoneal balance test ("PET") Referring now to Figure 2A, a cross section of a blood vessel of the peritoneum illustrates the three pores of the vessel. The three pores each have their own clearance of toxins and UF, leading to a kinetic model called a three-pore model. The three-pore model is a mathematical model that describes, correlates and anticipates the relationships between the time course of solution elimination, fluid transfer, treatment variables and physiological properties. The three-pore model is a predictive model that can be used for different types of dialysate, such as dialysates Dianeal®, Physioneal®, Nutrineal® and Extraneal® marketed by the assignee of the present disclosure.

The three-pore model is based on an algorithm, which is described below: dV D- - Jf, -c + Jv¡¡ + J L in which: DV is the volume of peritoneal fluid; JVc is the flow of fluid through the transceiular pores or aquaporins shown in Figure 2A; Jvs is the flow of fluid through small pores shown in Figure 2A; JVL is the fluid flow through large pores shown in Figure 2A; Y L is the peritoneal lymph flow.

Research has shown that the three-pore model and the two-combination model are essentially equivalent in terms of UF and a small solute clearance. The two-combination model is easier to implement than the three-pore model, because it requires less computational technique, and therefore less computer time. Research has also shown that the correlation between the anticipated results derived from the prediction software, versus the actual results measured from the real therapies, have, for the most part, a good correlation. Table 1 below shows results of a study (E. Vonesh and associates, 1999). The correlations (re) are accurate for the urea removed, weak clearance of urea (pKt / V), total clearance of urea (Kt / V), eliminated creatinine, weak clearance of creatinine (pCCr), total clearance of creatinine (CCr) , glucose absorption and total effluent (drainage volume). However, the UF correlation is not accurate, possibly due to: the UF volumetric accuracy of the APD device, the volume of residual solution in the patient, the variation of the patient's transport characteristics and the limited entry points to estimate the kinetic parameters key.

Table 1 Correlation Between the Kinetic Software Model and the Real Measured Results It has been discovered that certain APD devices can more accurately measure the volumes of fill and drain fluid. For example, the APD machine HomeChoice® / HomeChoicePRO® APD provided by the assignee of the present invention, has a total accuracy of reported fill and drain volume of 1% or +/- 10 ml_. An APD machine that uses multiple exchange cycles -i increases the data points needed to estimate the key kinetic parameters, and at the same time, reduces the possibility of introducing errors due to the volume of residual solution in the patient. Correspondingly, a new PET is proposed to improve the accuracy of UF prediction, maintaining and improving at the same time the current good prediction of small solutes (or toxins).

Figure 2B illustrates an alternative kinetic model (PD of two combinations) that the system 10 can use for PET 12. The two-combination PD kinetic model of Figure 2B, similar to that of Figure 2A, is used to anticipate the elimination of fluids and solute in PD to: (i) assist physicians in the care and management of patients; (I) assist physicians in understanding the physiological mechanisms that govern peritoneal transport; and (iii) simulate a therapy result. The set of differential equations that collectively describe the mass of both diffusion and convex transport in the compartments of both the body and dialysate for an "equivalent" membrane center, are as follows: Body compartment d (VtiCfí)! dt = g- KrA (C "- C0) - QusC - K! (C Dialysate compartment _ d (V0C0)! dt = KPA. { CB - C) + QvsC The diffusion mass transfer range is the product of the mass transfer area coefficient, KPA, and the concentrated gradient, (CB-CD). In turn, KPA is equal to the product of the permeability (p) of the solute membrane and the transfer area (A). The convective mass transfer range is the product of the net water removal (UF) range, Qu, is the sifted coefficient of the solute, s, and the concentration of the average membrane solute, C. KR is the coefficient of renal residual function.

When solving the above equations for the dialysis volume, VD, at time t is as indicated below: Dialysate Volume wherein (i) VD1 is the volume of dialysate immediately after the infusion (ml_); (ii) LPA 'is the range of hydraulic permeability transport (mL / min / mmol / L); (iii) K¡ * is the solute value ith 'of the mass transfer area coefficient (mL / min) ¡(iv) Sj is the ith of the solute sifting coefficient; (v) CD, ¡'is the ith of the dialysate concentration of the solutes immediately after the infusion (mmol / L); (vi) CB, ¡'is the ith of the concentration of blood in solutes immediately after the infusion (mmol / L); (vii) t is time (min); and (viii) QL ° is the lymphatic absorption (ml / min). Therefore UF can be calculated from the above equation knowing the infusion volume, the concentration of solution and the retention time.

To estimate the hydraulic permeability (LPA, mL / min / mmol / L) and the range of lymphatic flow, (QL> mL / min) for the above equation, two RV values are needed in the corresponding retention time t1 and t2 . The VD value (fill volume + UF) is difficult to measure due to incomplete drainage (recycle) and errors in the resulting UF measurement. The PET 12 as shown in Figure 3 uses multiple measures, eg, five, of the retention volume (RV) in multiple (five) different corresponding retention times, eg, overnight, 4 hours, 2 hours , 1 hour and a half hour, to improve the accuracy of the LPA and QL estimate and thus improve the accuracy of UF prediction.

In one embodiment, the PET 12 of the present description begins with an evaluation of UF versus retention time carried out during the course of two treatments (for example, two nights or later) by directly estimating the fluid transport parameters of the patient. patient and correlating the measured parameters with other PET results. The UF removed for a particular type of dialysate is measured by filling the patient with fresh dialysate, allowing the solution to remain within the patient's peritoneum for a prescribed time, draining the patient and subtracting the volume from the drainage volume to determine a UF volume for said particular retention time.

In one implementation, on a first night, using a standard dialysate, such as Dianeal® 2.5% dextrose dialysate, the APD machine administers four 2-liter fill / drain cycles: a first cycle in a retention time of 30 minutes; a second cycle in a 60 minute retention (1 hour); third cycle in a 120 minute retention (2 hours); and a fourth cycle in a retention of 240 minutes (4 hours). The total retention times is approximately 7 hours, 30 minutes, which includes the time required for filling and draining, consuming a total therapy time of approximately 8 hours. The APD machine records the fill volume, drain volume and actual retention time of each cycle. The filling volume can be slightly less than or greater than 2 liters depending for example that both fresh dialysate is actually existing at the start in the bag, and that both the APD machine can empty the bag. In any case, the fill and drain volumes are recorded accurately so that the resulting calculated UF is also accurate.

In an alternative modality, to increase the accuracy, the patient weighs the dialysate bag before filling and after draining. The weight values can be sent wirelessly from the scale to the APD machine (as described in more detail below). Alternatively, the patient enters the weight data manually. The APD machine subtracts the pre-drained weight of the pre-fill weight to accurately determine a UF value, which is checked against the actual retention time.

The retention time can be: (i) the time between the end of a fill and the start of the corresponding drain; (ii) the time between the start of a fill and the end of the corresponding drain; and (iii) in a preferred embodiment, the time between the end of a fill and the end of the corresponding drain. In any of the scenarios, the actual retention time will probably be slightly longer or shorter than the prescribed retention time. For example, in scenarios (ii) and (iii), a twisted line during drainage will lengthen the drainage time and therefore the retention time recorded. In scenario (ii), a twisted line during filling will lengthen the filling time and therefore the recorded retention time. The APD machine records the actual retention times to be used as shown below. The actual times, not the prescribed ones, are used so that any difference between the actual and prescribed retention times does not introduce an error in the UF predictive model.

The next day or the second night, using the standard dialysate (for example, Dianeal® 2.5% dextrose), the patient of the ADP machine administers a simple filling volume with a retention of 480 minutes or 8 hours. The APD machine records a real retention time (according to any of the scenarios (i) to (iii) above) and compares the actual retention time with the actual UF recorded (for example through the APD or weight scale) ) on the APD machine.

At the end of the two days, the APD machine has five UF data points / retention time recorded (however, more or fewer data points can be achieved)., the five previous retention times are acceptable and can be achieved in two 8-hour therapies). In one embodiment, the APD machine sends the UF data points / retention time to a server computer located in the office of clinic 120 or doctor 110 of dialysis (figures 15A, 15B, 16A and 16B), where it is carried the rest of the PET 12 is carried out. In the present invention various modalities are shown for linking the APD machine to a server computer, for example, an email link can be used to carry data. In another embodiment, the APD machine registers the five (or other number) data points on a patient data card, which the patient inserts into the APD machine. The patient then carries the data card and the accompanying data to the dialysis center 120 or to the doctor's office 110 to complete PET 12.

The patient then travels to the dialysis center or doctor's office, for example, the next day. The patient is filled with an additional time and drained normally after 4 hours. Blood and dialysate samples are taken, for example at 2 hours and 4 hours. A second UF retention data point of 4 hours can be taken and compared to the first retention UF data point of 4 hours for additional accuracy. Alternatively, the second blood sample is taken at 4 hours, although the patient is drained, for example, at 5 hours, providing additional UF retention data points.

Figure 3 illustrates a trace of the UF data points for the different real retention times. The server computer, or other computer software of the physician, is programmed to fit a curve 30 to the five data points. Curve 30 fills the openings between the different retention periods recorded (for example, 0.5 hour, one hour, two hours, four hours and eight hours) and thus anticipates the UF that will be eliminated from any retention period within the handle eight hours and beyond, and for the level of dialysate and dextrose used.

The osmotic gradient created by the dextrose in the dialysis solution decreases with time as the dextrose is absorbed by the body. The ultrafiltration range of the patient therefore begins at a high level and decreases with time to a point at which the range becomes really negative, so that the patient's body begins to reabsorb fluid. Therefore, the UF volume as shown in the graph can actually decrease after a certain retention period. One of the goals of the present description is to learn the optimal UF retention time of the patient, which may be dependent on the dextrose level, and incorporate the optimal retention time (s) in the prescriptions described in detail below.

In the illustrated mode, curve 30 anticipates the UF eliminated for the dextrose percentage of 2.5. Once the curve is adapted to a particular patient, later the curve can be calculated using the kinetic model to anticipate the values of UF / retention time for other dialysates and other levels of dextrose, for example, 1.5% and 4.25% of dextrose levels. As shown in Figure 3, for the 2.5% dextrose, the curve 30 has a maximum UF retention time removed of about three hundred minutes or five hours. Probably five hours is a too long retention time, however, UF for a retention time of two hours or 2.5 hours becomes very close to the retention time of maximum UF. A retention time of two hours is much closer to the maximum of 1.5% dextrose. The 4.25% dextrose itself leads to longer retention times as seen in Figure 3. For example, a one-day exchange is a good application for the 4.25% dextrose.

In addition to anticipating the optimal UF data points, the five or six UF data, the blood test and dialysate test data are taken using a particular dialysate, such as Dianeal® dextrose 2.5% dialysate. Each UF, blood and dialysate data is used to generate mass transfer area coefficient data ("MTAC") and hydraulic permeability data to classify the transport and UF characteristics of the patient. The MTAC data and the hydraulic permeability data can subsequently also be applied physiologically to other types of dialysates such as 1.5% or 4.5% dextrose solutions and for different formulations such as Extraneal® and Nutrineal® dialysates provided by the transferee. the present description. That is, curve 30 is shown for a concentration. However, once the kinetic model and LPA and QL are known (from the results of the PET test), the system 10 can calculate the RV according to the previous algorithm, for each of the types of solution, Dextrose concentration, retention time and filling volume. An LPA value of 1.0 (mL / min / mmol / L) and a QL value of 0.8 ml / min were used in the simulation for curve 30 (dextrose at 2.5%) and curves for dextrose at 1.5% and dextrose. to 4.25% of figure 3.

A kinetic modeling simulation was carried out using the previous algorithm for the volume of dialysate VD, and the data shown in table 2 below was generated, which shows a comparison of the estimated UF and the associated error using a known PET and PET 12. The data showed that PET 12 significantly improved UF prediction accuracy compared to a known PET.

Table 2 Accuracy of UF Anticipation Using PET 12 Generation of Automatic Regime As shown in Figure 1, the system 10 of the present invention includes a therapy regimen generation module 14. The regimen generation module 14 includes a plurality of prediction algorithms. The prediction algorithms use the characteristics of UF and patient transport calculated previously from the PET 12, objective information and other input information to the therapy to generate the regimes. The regimen generation module 14 in one modality generates all possible therapy regimens that meet the objective requirements entered using the therapy input information and the calculated UF and patient transport characteristics. The regimes generated are as many as those shown below. Subsequently, the prescription generation module 16 filters the regimes generated in the module 14 to produce a finite number of optimized prescriptions that can be carried out in the APD machine for the particular patient.

Figure 4A shows a data entry screen for the regime generation module 14. The data entered on the screen of Figure 4A are obtained from the PET 12. Figure 4A provides PET 12 data entry for the nurse of clinic of the dialysis center. The data include the UF measurement of dialysate, the dialysate laboratory test results (urea, creatinine and glucose), and the results of the blood test (urea, creatinine and serum glucose). Specifically, an "overnight exchange" module of Figure 4A provides the exchange data input overnight, including: (I) percentage of dextrose, (i) type of solution, (iii) volume of solution infused, (iv) volume of drained solution, (v) retention time (s), (vi) urea concentration in dialysate (result of laboratory test of drained dialysate), and (vii) dialyzed creatinine concentration (results of drained dialysate laboratory test). A "Four Hour Equilibrium" module of Figure 4A provides the four hour exchange data entry, which is normally obtained from a patient's blood sample taken from a physician, where the data includes: (i) percentage of dextrose, (ii) type of solution, (iii) volume of infused solution, (iv) volume of drained solution, (v) infusion time, and (vi) drainage time. A "Data" module of Figure 4A provides the four-hour exchange data entry, including: (i) serum sample time # 1 (typically 120 minutes after dialysate infusion), urea concentration, creatinine , and glucose, which are the doctor's entries, "Correct Crt" is the corrected creatinine concentration that calculates the software's algorithm; (ii), (iii) and (iv) for the dialysates # 1, # 2 and # 3, sample time, urea concentration, creatinine, and glucose, which are the doctor's entries, "Corrected Crt" and " CRT D / P "(creatinine in dialysate / plasma creatinine) that are calculated by the software.

In Figure 4B, the "serum concentration" module involves a blood test which is normally carried out after a regular APD therapy, preferably in the morning, leading to the result sent to the laboratory for analysis of creatinine, urea, glucose, and albumin. Serum concentration (sometimes called plasma concentration) are the results of the laboratory test of urea concentration, creatinine and glucose in the blood. A patient with end-stage renal disease has levels of urea and creatinine in the blood that are much higher than for people with functioning kidneys. The glucose concentration is important because it measures how much glucose the patient's body absorbs when using a dextrose-based solution. The "24-hour dialysate and urine collection" module in Figure 4B shows that the patient does not have residual renal function, therefore he does not produce urine. The data collected during the night are used to calculate the residual kidney function of the patient ("RRF"), the results of the APD therapy (results of filling test, drainage and laboratory) and to measure the height and weight of the patient. patient to calculate the area of the patient's body surface ("BSA"). As observed in the example for the second day of PET 12, (eight hour retention), without melting 8000 milliliters of dialysate in the patient, 8950 milliliters of dialysate were eliminated from the patient, producing a net UF volume of 950 milliliters. The dialysate is sent to the laboratory for the analysis of urea, creatinine, and glucose. A "weekly clearance" module calculates the weekly Urea Kt / V and the weekly creatinine clearance ("CCL"), which are parameters that the doctor uses to analyze if the patient has an adequate clearance.

Figure 4C of the generation characteristic of the regime 14 shows a sample screen in which the system 10 calculates the mass transfer coefficients ("MTACs") and the water transport parameters using the data of the screens 4A and 4B and the stored algorithms. The RenalSoft ™ software provided by the assignee of the present invention is known software for calculating the data shown in FIG. 4C from the input data of 4A and 4B. Some of the data calculated and shown in Figure 4C are used in an algorithm for the regime generation characteristic 14. Specifically, the regime generation algorithm uses the MTACs for urea, creatinine and glucose, and hydraulic permeability to generate the regimes.

Figure 4D of the regime generation characteristic 14 shows the clinic or doctor the anticipated drainage volumes determined based on the hydraulic permeability of Figure 4C versus the actual UF measured from the PET 12. The results are shown for an overnight exchange (eg, night one or two PET 12) and for the four-hour retention test carried out in the dialysis center 120 or in the doctor's office 110. The difference between the actual drainage volume UF and the anticipated draw volume is calculated so that the clinic or doctor can see the accuracy of PET 12 and the prediction routines from 4A to 4D for the volume of UF drainage. To generate the anticipated drainage volumes, the operator enters a fluid absorption index. The machine also calculates a fluid absorption value used in the prediction of drainage volume. As can be seen in figure 4D, the system software 10 has calculated the range of fluid absorption to be 0.1 ml / min based on the entered values of the PET of the patient. As seen in the upper part of figure 4D, the actual drainage volume versus the anticipated volume for overnight exchange was 2200 mi versus 2184 mi. The anticipated drainage versus the actual four-hour (day) drainage was 2179 mi versus 2186 mi. The lower part of Figure 4D shows the actual versus anticipated drainage values for the most common fluid absorption range of 1.0 ml / min, which are not as close to each other as those in the fluid absorption range of 0.1 ml / min. The system can then ask the doctor to enter a range of fluid absorption that you want to use for this patient when UF is anticipated, which is usually between and including 0.1 ml / min and 1.0 ml / min.

Figure 5 illustrates an input table of possible regime calculations for the regime generation characteristic 14. The regime calculation input table enters "Clinic Objectives" data including (a) minimum urea clearance, (b) Kt / V of minimum urea, (c) minimum creatinine clearance, (d) maximum glucose absorption, and (e) target UF (eg, in twenty-four hours to four hours).

The table in Figure 5 also enters the Night Therapy Parameter data such as (i) therapy time, (ii) total therapy volume, (iii) filling volume, (iv) percentage of dextrose for the type of chosen solution, and possibly (v) type of solution. Here, the retention times and exchange number are calculated from (ii) and (iii). The retention time can alternatively be adjusted to the results of PET 12 as described above, which can be used in combination with at least one other input, such as total time, total volume, filling volume to calculate the rest of the entries of total time, total volume and filling volume. For example, if the retention time, total volume and total time are adjusted, the system 10 can calculate the filling volume per exchange and the exchange numbers. The input of Night Therapy Parameters also includes the last filling entries, such as (i) retention time, (ii) last filling volume and (iii) percentage of dextrose for the type of solution chosen.

The table of figure 5 also enters the data of the Parameters of the Day Therapy, such as (i) time of therapy, (ii) volume of filling of the day, (iii) number of cycles, (iv) percentage of dextrose for the type of solution chosen, and possibly (v) type of solution. The exchanges of the day may or may not be carried out.

The type of solution for nocturnal and daytime therapies is chosen from a part of Solutions of the table of entry of Figure 5, which enters the dextrose levels available, the formulation of the solution (for example, Dianeal® dialysates, Physioneal ®, Nutrineal®, and Extraneal® marketed by the assignee of the present invention) and bag size. Bag size can be a weighty aspect especially for elderly patients. Smaller pockets may be needed for regimens that use a different last fill and / or exchange solution of the day or dextrose level. Smaller pockets may also be needed for regimens that invoke a dextrose level that requires a mixture of two or more standard dextrose level pockets (eg, dextrose level of 2.0%, 2.88%, 3.38%, or 3.81%) described under the Solutions portion of the table of Figure 5. Mixing to produce the customary level of dextrose is described below in relation to Figure 14. Inventory management of solution bags is also described below in relation to with figures 10 to 13.

The input table of the calculation of the scheme in Figure 5 also illustrates that many of the entries have ranges, such as plus / minus ranges for the Physician's Objectives data and the minimum / maximum / incremental ranges for certain Parameter Data. Nocturnal therapy and data of Parameters of Day Therapy. Once the doctor or doctor begins to complete the table of figure 5, the system 10 automatically places suggested values in many of the other cells, minimizing the number of entries. For example, the solutions available under the Solutions data can be filled automatically based on the solutions that have been indicated as available and through the dialysis center, which is based additionally on the portfolio of the available solution approved by the specific country. In another example, the system 10 can adjust the fill volume increments for the Night Therapy Parameter data automatically to use all available solutions (for example, when a twelve liter therapy is being evaluated, the number of cycles and Filling volumes can fluctuate as follows: four filled with 3000 ml_, five filled with 2400 mL, six filled with 2000 ml_ and seven filled with 1710 mL). The system 10 allows the operator to change, if desired, any suggested values.

The system software 10 calculates the anticipated results for all possible combinations of parameters based on the ranges that are entered for each parameter. As shown in Figure 5, some regimens will have "adequate" anticipated results for urea clearance, creatinine clearance, and UF that meet or exceed the minimum criteria selected by the physician. Others no. Selecting the option "Deploy Only Appropriate Regimes" speeds up the regime generation process. Some patients may have hundreds of regimens that are adequate. Others may have only some or possibly even none. When none is adequate, it will be necessary to deploy all regimes so that regimes that are close to meeting the objective requirements can be identified for filtering. Filtration when initiated with all regimens deployed, provides the doctor / doctor with the greatest flexibility when trying to find the best prescription for the patient.

The system 10 feeds all the therapy combinations in the result anticipation software and tabulates the results in the table, so that the 10 can filter as shown below in relation to the filtering prescription module 16. A software suitable is the RenalSoft ™ software provided by the assignee of the present disclosure. The combinations take into account the different ranges previously entered in the regime calculation input table of Figure 5.

Table 3 below shows the first ten results (out of a total of 270 results) for a set of data entered into the system software. Here, a 1.5% nocturnal dextrose solution is chosen. A day exchange is not allowed. The results generated are shown for standard PD therapy but as an alternative, or additionally, they can be generated for other types of PD therapy, such as tidal therapy. Figure 5 has a review table that allows either or both of the continuous recycling peritoneal dialysis ("CCPD") or tidal therapies to be included in the regimen generation process.

Table 3 APD Therapy As shown, Table 3 illustrates ten of two hundred and seventy valid combinations, possible with a nocturnal dextrose level of 1.5%. The same two hundred and seventy combinations will also exist for the dextrose level of 2%, 2.5%, etc., level of nocturnal dextrose. An equal number of valid combinations is created for each possible level of dextrose when a day fill is added. In addition, the last fill retention time may vary to create even more valid combinations.

Prescription filtering As shown above, the system 10 allows the clinic / doctor to prescribe values for clinical objectives and therapy inputs, such as filling volume, total therapy volume, total therapy time, etc. of the patient and generates a table, such like table 3, which contains all the therapies that meet all the medical requirements. The therapy table that meets all the medical requirements, can then be automatically filtered and classified based on parameters such as the total night therapy time, the cost of therapy solution and therapy weight, etc.

The software uses one or more algorithms in combination with the therapy combinations (for example of Table 3) and the physiological data of the patient generated by PET 12, as shown in relation to Figures 4A to 4D, to determine the results of anticipated therapy. The combinations of the therapy (for example, from Table 3) that meet the Clinical Trials of Figure 5 are filtered and presented to the clinic, nurse or doctor as candidates to become prescribed regimens.

Figures 6A and 6B illustrate examples of filters that the doctor or clinic can use to eliminate regimens. In Figure 6A, the elimination of Urea Kt / V minimum of 1.5 is increased in Figure 5 to 1.7 in Figure 6A. In one embodiment, the range from +0 to -0.2 in Figure 5 is automatically applied to the new minimum value set in Figure 6A. As an alternative, the system 10 warns the user that he has to enter a new range or maintain the same rank. A Boolean "And" operator is applied to the new Urea Kt / V minimum to specify that the value must be met, subject to the applied range, in combination with the other clinical objectives.

In Figure 6B, the minimum twenty-four hour UF removal of 1.0 is increased in Figure 5 to 1.5 in Figure 6B. In one embodiment, the range from +0 to -0.2 in Figure 5 is applied again automatically to the new minimum value set in Figure 6B. As an alternative, the system 10 warns the user that he has to enter a new daily UF range or maintain the same UF range. Again, a Boolean "And" operator is applied to the new minimum UF of twenty-four hours to specify that the value must be met, subject to the applied range, in combination with the other clinical objectives. The doctor and the patient are free to impose additional clinical and non-clinical requirements, such as: cost of the solution, weight of the solution bag, absorbed glucose, night therapy time, filling volume of the day, filling volume of the night.

Referring now to Figure 7A, the regimes that meet the Clinical Objectives and other entries of Figure 5 and the additional filtration of Figures 6A and 6B are shown. As can be seen, each of the regimens is anticipated to eliminate at least 1.5 liters of UF per day and has a minimum Urea Kt / V elimination greater than 1.5.

Regimen 36 is signaled because it has the smallest day filling volume (patient comfort), the lowest solution weight (patient's convenience) and the next value at the lowest glucose absorption value (minimal impact on the diet). Therefore, regimen 36 is chosen and prescribed by a doctor as a standard UF regimen.

The patient, clinic and / or doctor can also lift one or more additional prescriptions for approval so that it also meets the needs of the patient's lifestyle. It is assumed as an example, that the patient is a member of a bowling team during the winter months competing in a Saturday night league. He drinks a little more than normal while he is socializing. The patient and his doctor / clinic agree on a therapy regimen that eliminates approximately 20% more UF than it should be.

Carry out the Saturday nights. Likewise, in bowling nights, the patient only has seven hours to carry out the therapy instead of a standard therapy of eight hours. The filtered potential prescription 34 indicated in Figure 7A is therefore approved as a higher UF prescription, which uses a higher concentration of dextrose to eliminate the extra UF and perform it in the required seven hours.

In addition, assume that the patient lives in a southern state and works on weekends during the summer months (without a bowling league) and therefore loses a substantial amount of body fluid due to perspiration. The doctor / clinic and the patient agree that less than 1.5 liters of UF need to be eliminated in these days. Because Figure 8 only shows regimes that eliminate 1.5 liters or more of UF, an additional filtration is used to provide low level UF regimes for possible selection as a low level UF prescription.

The doctor or clinic uses an additional filtering of the twenty-four hour UF screen of Figure 6C to restrict the previous range of the daily FU that the regimen must meet. Here, the doctor / clinic looks for regimens that have daily UF eliminations greater than or equal to 1.1 liters and less or equal to 1.3 liters. The Boolean "And" operator is selected so that the therapy meets all the other clinical requirements of Figures 5 and 6A.

Referring now to Figure 7B, the regimens that meet the Clinical Objectives and other entries of Figure 5 and the additional filtrations of Figures 6A and 6C are shown. As can be seen, each of the regimes is anticipated to eliminate the following values or between the following values of 1.1 and 1.3 liters of UF per day, while complying with the elimination of Urea Kt / V minimum greater than 1.5 and other clinical objectives. The doctor / clinic and the patient subsequently decide with respect to a tidal therapy regimen 58 (indicated), which does not require a day exchange, and requires the shortest nighttime therapy time. Later the doctor prescribes the therapy.

Referring now to Figures 8A to 8C, the three agreed-upon prescriptions of high level UF, standard UF and low level UF, respectively, are illustrated. The prescriptions are named so that they are easily recognizable by patient 102, doctor 110 and clinic 120. Although in this example three prescriptions are shown, system 10 may store other numbers of suitable prescriptions, as described herein. The system 10 downloads the parameters of the prescription into a data card in a modality, which is subsequently inserted into the APD 104 machine, transferring the prescriptions to the non-volatile memory of the APD machine. As an alternative, the prescriptions are transferred to the APD machine 104 through a wired data communication link, such as through the internet. In one modality, the patient has the freedom to choose which prescription will be carried out on a particular day. In an alternative modality, the data card or data link transfer of the prescriptions, is entered in the memory of the dialysis instrument, so that the instrument administers a prescribed treatment every day automatically. These modalities are described in detail below in relation to the repetition and prescription adjustment module 26. In any case, when the patient initiates with any of the therapies, the system 10 provides instructions in which the solution bags are connected to the patient. a disposable pump cartridge, since therapies can use different solutions.

Figures 9A to 9E illustrate another filtering example of module 16. Figure 9A illustrates filtered configurations on the left side and the corresponding results on the right side, which produces 223 possible regimes. In Figure 9B, the clinic additionally filtered regimens by limiting the filling volume of the day (patient comfort) to 1.5 liters. This filtration reduces the possible regimens to 59. In Figure 9C, the clinic software additionally filters the regimens by decreasing the regimens to 19. In Figure 9D, the physician additionally filters the available regimens by reducing the absorbed glucose to 500 Kcal / day. This action reduces the available regimes to three.

Figure 9E shows the three filtered regimens that can either be prescribed by the clinic, or discarded to allow another filtering exercise to be carried out. The exercise of Figures 9A to 9D shows that the optimization of prescription becomes convenient with respect to the physiological characteristics of the patient that are known. Figures 9A to 9D also show a suitable list of possible filtering criteria.

Inventory tracking Referring now to Figures 10 to 13, an embodiment of an inventory tracking module or subsystem 18 of system 10 is illustrated. As described in the present invention, system 10 generates agreed-upon prescriptions, such as UF prescriptions of high level, standard UF and low level UF as shown in relation to figures 8A to 8C. The different prescriptions require different solutions as shown in Figure 10. Figure 10 shows that the standard UF prescription uses twelve liters of Dianeal® dialysate at 1.5% and 2 liters of Extraneal® dialysate. The prescription of high-level UF uses fifteen to eighteen (depending on the alternative dialysis used) liters of dialysate 1.5% Dianeal® and 2 liters dialyzed Extraneal®. The low-level UF prescription uses twelve liters of Dianeal® dialysate at 1.5% and three liters of Dianeal® dialysate at 2.5%.

Figure 11 shows an example screen that a server in dialysis center 120 can display for a patient having the above three prescriptions. The screen in Figure 11 shows the minimum base supply inventory required for the three prescriptions in a supply cycle. The screen of figure 11 shows that the patient will be provided with the solutions necessary to carry out the thirty-two standard UF prescription therapies. The patient will be provided with the necessary solutions to carry out six high-level UF prescription therapies. The patient will also be provided with the necessary solutions to carry out six low level UF prescription therapies. The patient will be additionally provided with an "ultra-bag" case (six 2.5-liter bags). The trunk of a Y-shaped ultra-thin pouch fit can be connected to the patient transfer setting. An empty bag is attached to one leg of the Y and one full bag is previously attached to the other leg of the Y. The ultra-bag is used to carry out CAPD exchanges if the APD machine is stopped, if power is lost and if not You can operate the APD machine or if the patient is traveling and your supply does not arrive on time.

In addition, the patient is also supplied with forty-five disposable groups (one used for each treatment) that includes a disposable pump cartridge, a bag line, a patient line, drain line, heating bag and associated fasteners and connectors. The patient is supplied with dialysis solutions with low dextrose concentration (1.5%), medium (2.5%) and high (4.25%), so that the patient can eliminate more or less fluid, commuting with the level of dextrose used. The flexibility of the prescription (including mixing) can increase the total number of bags needed for a given month until approximately forty-five days of solutions.

The patient will also be supplied with forty-five caps or flexitaps, which are used to cover the patient's transfer facility and when the patient is not connected to the recycler. Flexitaps contain a small amount of povidone iodine to minimize the potential for bacterial growth due to contact contamination.

Figure 12 shows an example screen that can be deployed by the dialysis center 120 for a patient having the above three prescriptions. The screen in Figure 12 shows the expected actual inventory of the patient at the time when a new supply of inventory is made. That is, the screen in Figure 12 shows the inventory that the server computer assumes will be in the patient's home when the supply person arrives. In the example, the server computer expects that when the person from When the supply reaches the patient's home, the patient will already have: (i) five cases (two bags per case) of Dianeal® 1.5% dialysate containing six liter bags, (ii) one case (four bags per case) of dialysate 2.5% Dianeal® containing three liter bags, (ii) one case (six bags per case) of Extraneal® dialysate containing two liter bags, (iv) forty-four disposable sets (of a case of thirty) , including each of the devices described above, (v) two 1.5 liter dialysate Ultra-Bags of 1.5% (of a case of 6), and six caps or flexitaps (of a case of thirty).

Figure 13 shows an example screen, which the dialysis center server 120 can display, for a patient having the above three prescriptions. The screen in Figure 13 shows the actual inventory that will be supplied to the patient. That is, the screen in Figure 13 shows the difference in inventory between what the patient is supposed to have at the beginning of the inventory cycle and what the server computer assumes is in the patient's home when the supply person arrives. In the example, the patient needs: (i) eighty eight, six liter bags of Dianeal® 1.5% dialysate, has ten at home, reducing the need for seventy eight bags or thirty nine cases (two bags per case); (ii) six, three liter bags of 2.5% Dianeal® dialysate, four at home, reducing the need for two bags or one case (4 bags per case, resulting in two extra supplies); (iii) thirty-eight, 2 liter bags of Extraneal® dialysate, has six at home, reducing the need for thirty-two bags or six cases (six bags per case, resulting in four extra supplies); (iv) forty-five disposable sets, has twenty-four at home, reducing the need for twenty-one or one case (thirty per case, resulting in nine disposable sets supplied extra); (v) six, 1.5-liter 2.5-liter bags, you have two at home, reducing the need for four bags or one case (six bags per case, resulting in two extra bags supplied); and (vi) forty-five flexitapas, he has thirty-six at home, reducing the need to nine or one case (thirty-six per case, resulting in twenty-seven extra flexitapas supplied).

In one embodiment, the server database of the dialysis center of the inventory tracking module 18, maintains and knows: (a) that both dialysate and other supply are assumed to have the patient at the beginning of a supply cycle; (b) the different prescriptions of the patient, solutions used with each, and the number of times each prescription will be used during the supply cycle; and (c) consequently, how much the patient is supposed to have of each dialysate to be used during a supply cycle. Knowing the above, the inventory tracking server can calculate how much each solution and other supplies need to be supplied on the next supply date. There are opportunities that the patient has consumed more or less of one or more solutions and another product than expected. For example, the patient may have punctured a solution bag, which subsequently had to be discarded. The patient may misplace a solution bag or other product. Both cases result in consuming more inventory than expected. On the other hand, the patient may skip one or more treatments in the course of the supply cycle, resulting in less inventory being consumed than expected. In one modality, the follow-up module or subsystem 18 of system 10, expect that the number of solutions and other estimated supplies are close to the actual amount needed. If too much inventory is provided, (the patient used less than prescribed), the supply person can supply the extra inventory to the patient and explore or otherwise observe the additional inventory, so that it can be stored in the inventory server's memory . For the next cycle, the system 10 updates (for example, increases) the preceding subsection (a), that is, that both of each dialysate and another supply is assumed to have the patient at the beginning of the supply cycle. As an alternative, the supply person only supplies the amount of inventory needed, so that a real inventory of the patient is made at the beginning of the supply cycle equal to the inventory expected in subsection (a) above. If not enough inventory is scheduled for the supply (solution damaged or lost by the patient or related supplies, for example) the supply person carries extra inventory to make the actual inventory of the patient at the beginning of the supply cycle equal to the expected inventory in subsection (a) above.

The inventory subsystem 18 of system 10 in one mode maintains additional information, such as the individual cost of supplies, the weight of supplies, alternatives for required supplies, and the patient exhausts the supplies required during the supply cycle. As shown previously in Figures 7A and 7B, the regime generation software in a modality uses or generates the weight and cost data as a potential factor or factor to determine which regimes will be selected as prescriptions. The dialysis center server 120 downloads (or transfers via a data card), the data of the alternative solution to the patient's APD recycler. In one implementation, when a patient begins therapy, the patient is notified of the particular solution bag (s) necessary for the prescription of that particular day. If the patient administers a type of solution, the system can provide an alternative based on the solutions maintained in the current inventory.

Mixed Dextrose As shown above in Figure 5, system 10 contemplates the use of a plurality of different levels of dextrose for each of the different brands or types of dialysates available, which increases the doctor / physician's options to optimize prescriptions. for the patient. The negotiation with dextrose is generally so that higher levels of dextrose eliminate more than UF but have a higher caloric intake, making weight control more difficult for the patient. The inverse is also real. Dialysate (at least certain types) is provided at different levels of standard dextrose including 0.5%, 1.5%, 2.5%, and 4.25%. As seen in Figure 6, the nocturnal dextrose, last dextrose filling and day dextrose can be chosen to have any of the above standard percentages or have a combined dextrose level of 2.0%, 2.88%, 3.38% or 3.81%. The system 10 uses the dialysis instrument 104 to mix the standard percentages to create the combined percentages. It is already considered that each of the standard dextrose level dialysates have been approved by the Federal Drug Administration ("FDA") and that the combined levels of dextrose are within the approved levels said mixed can easily comply with the probation by FDA.

Table 4 Proportions of Mixing Glucose-Based Solutions v Concentrations Using a 1: 1 or 1: 3 mixture shown in Table 4, more dextrose solutions are generated, providing physicians with more therapy options. At the same time, these mixing ratios will use the entire solution in a container, resulting in no waste.

Referring now to Figure 14, the dialysis instrument 104 illustrates an apparatus with the ability to produce the combined dextrose level dialysates. The dialysis instrument 104 is illustrated as being a HomeChoice® dialysis instrument, marketed by the dialysate transferee of the present invention. The operation of the HomeChoice® dialysis instrument is described in many patents including U.S. Patent No. 5,350,357 ("The '357 patent"), the total contents of which are incorporated herein by reference. Generally, the HomeChoice® dialysis instrument accepts a disposable fluid cartridge 50, which includes pump chambers, valve chambers and fluid flow paths that interconnect and communicate in the form of fluids with various tubes, such as the tube that goes to / from the heating bag 52, a drain tube 54, a patient tube 56 and dialysate supply tubes 58a and 58b. Although Figure 14 shows two supply tubes 58a and 58b, the dialysis instrument 104 and the cartridge 50 can support three or more supply tubes and therefore three or more supply bags. In addition, as noted in the '357 patent, one or both of supply tubes 58a and 58b can be connected to two supply bags if more supply bags are needed.

In one embodiment, the system 10 pumps fluid from a supply bag (not shown) through one of the supply tubes 58a or 58b, the cartridge 50, to a more warm bag (not shown) located in the heating tray of the APD 104. The warmer bag provides an area for the solutions to mix before being delivered to the patient. In such a case, the more tempered bag can be adapted with one or more conductive strips, which allow temperature-compensated conductivity readings of the mixed solution to be taken, to ensure that the solutions have been mixed properly. As an alternative, APD 104 uses on-line heating, in which case the mixing is carried out inside the tubing and inside the peritoneum of the patients.

To operate cartridge 50, the cartridge is compressed between a cartridge actuation plate 60 and a door 62. Patent '357 describes a flow management system ("FMS"), in which fluid volume is calculated pumped from each pump chamber (the cartridge 50 includes two in one embodiment), after each stroke of the pump. The system adds the individual volumes determined by FMS to calculate an amount of the total fluid delivered and removed from the patient.

System 10 contemplates providing pump runs of different standard dextrose supplies using FMS to achieve a desired combined dextrose. As shown in Table 4 above, a standard 1.5% dextrose delivery bag can be connected to a 58a supply line, while a standard 4.25% dextrose delivery bag is connected to a 58b supply line . The dialysis machine 104 and dialysate of the cartridge pump 50 of each supply bag in a 50/50 ratio uses FMS to achieve a combined dextrose ratio of 2.88%. In another example, a standard 2.5% dextrose delivery bag is connected to a supply line 58a, while a standard 4.25% dextrose delivery bag is connected to a supply line 58b. The dialysis machine 104 and dialysate of the cartridge pump 50 of each supply bag in a 50/50 ratio uses FMS to achieve the combined dextrose ratio of 3.38%. In a further example, a standard 2.5% dextrose delivery bag (e.g., 2 L bag) is connected to a 58a supply line, while a standard dextrose supply bag of 4.25% is connected (e.g. , bag 6 L) to a supply line 58b. The dialysis machine 104 and dialysate of the cartridge pump 50 of each supply bag in a ratio of 25/75 (2.5% to 4.25%) uses FMS to achieve the combined dextrose ratio of 3.81%.

The first two examples may include a connection of a six-liter dialysate bag from each of lines 58a and 58b. In the third example, a standard 2.5% dextrose delivery bag is connected to a 58a supply line, while a 3.25% three-liter supply bag is connected in a Y-shape to a six-ounce supply bag. liters of 4.25%, both of which are connected to supply line 58b. The dialysis machine 104 and the dialysate of the cartridge pump 50 of each supply bag is connected to a heating bag in one embodiment, which allows the two different dialysate dextrose to be thoroughly mixed before being pumped from the heating bag to the patient. Accordingly, the system 10 can achieve the combined dialysate proportions shown in Figure 6 and others by pumping different levels of standard dextrose in different proportions using FMS. The dialysis instrument 104, in one embodiment, is configured to read bag identifiers to ensure that the patient connects the appropriate dialysates and the proper amounts of dialysate. Systems and methods for automatically identifying the type and amount of dialysate in a supply bag are set forth in U.S. Patent Application No. 11 / 773,822 ("the '822 Application"), entitled "System of Self-Identification of Radio Frequency ", presented on July 5, 2007, assigned to the assignee of the present description, whose total contents are incorporated into the present invention as a reference. The '822 Application discloses a suitable system and method for ensuring that the appropriate supply bags are connected to the appropriate doors of the cartridge 50. The system 10 can alternatively use a barcode reader that reads a bar code placed on the bag. or container for the identification of volume / type of solution. In the case in which Y-connections are needed, the APD machine 104 can warn the patient to confirm that the connection (s) -Y has been made to an additional bag (s).

U.S. Patent No. 6,814,547 ("the '547 patent") assigned to the assignee of the present disclosure, discloses a pumping mechanism and volumetric control system in relation to Figures 17A and 17B and associated described descriptions incorporated in the present invention. as a reference, they use a combination of pneumatic and mechanical performance. Here, the volume control is based on the precise control of a graduation motor actuator and a pump chamber of known volume. It is contemplated that this system instead of FMS of the '357 patent achieves the above combined dextrose levels.

Therapy Data Loading Communication Module Y Prescription Download Referring now to Figure 15A, network 100a illustrates a wireless network or communication mode 20 (Figure 1) for communicating PET, regime generation, filtering prescription, inventory tracking, trend modification information and prescription (more forward) between the patient 102, the doctor 110 and the dialysis center 120. Here, the patient 102 operates a dialysis instrument 104, which communicates wirelessly with a router 106a, which is in wired communication with the modem 108a . Doctor 110 operates the computer of the doctor (or nurse) 112a (who can also connect to a doctor's network server) who communicates wirelessly with a router 106b, which is in wired communication with a modem 108b. The dialysis center 120 includes a plurality of day clinic computers 112b to 112d, which are connected to a day clinic network server 114, which communicates wirelessly with a router 106c, which is in wired communication with a modem 108c. The modems 108a to 108c communicate with each other through an internet 116, wide area network ("WAN") or local area network ("LAN").

Figure 15B illustrates an alternate wired network 100b or communication module 20 (Figure 1) for communicating PET, regimen generation, filtering prescription, inventory tracking, trend modification information and prescription (below) between the patient 102, the doctor 110 and the dialysis center 120. Here, the patient 102 includes a dialysis instrument 104, which is in wired communication with the modem 108a. Doctor 110 operates the computer of the doctor (or nurse) 112a (which can also be connected to a network server), which is in wired communication with a modem 108b. The dialysis center 120 includes a plurality of clinic computers 112b to 112d, which are in wired communication with a 108c modem. The modems 108a to 108c again communicate with each other through an internet network 116, WAN or LAN.

In one embodiment, the data points of the curve 30 of Figure 3 are generated in the instrument 104 and are already sent to the doctor 110 or to the dialysis center 120 (most likely to the dialysis center 120), which houses the software to adjust curve 30 to the data points. Subsequently, the patient travels to the dialysis center 120 to carry out the blood work and complete the PET as described in the present invention. The software configured to administer the PET and the rate generating screens of Figures 4A, 4B, 5A, 5B and 6, can be stored in the clinic server 114 (or individual computers 112b to 112d) of clinic 120 or 112a computers from 110 doctor (most likely clinic 120) from system 100a or 100b. Similarly, the software configured to administer the filtering and prescribing optimization screens of Figures 6A to 6C, 7A, 7B, 8A to 8C and 9A to 9E on server 114 (or individual computers 112b to 112d) can be stored. of Clinic 120 or 112a computers from Doctor 110 of System 100a and 100b.

In one embodiment, the dialysis center 120 administers the PET, generates the regimens and filters of the prescriptions. The dialysis center 120 through the network 100 (referring to either or both of the networks 100a and 100b) sends the prescriptions to the doctor 110. The filtration can be carried out with an entry by the patient through the patient. any 100 network, phone or personal visit. The doctor reviews the prescriptions to approve or disapprove. If the doctor disapproves, the doctor can send an additional or alternative filtering criterion through the network 100 back to the dialysis center 120 to carry out the additional filtering to optimize a new set of prescriptions. Eventually, either the dialysis center 120 or the doctor 110 sends approved prescriptions to the instrument 104 of the patient 102 through the network 100. Alternatively, the dialysis center 120 or doctor 110 stores the prescriptions and the instrument 104 approved and, on a given day, consult the dialysis center 120 or doctor 110 through the network 100, to determine which prescription to administer. The prescriptions can be alternatively transferred additionally through a data card.

In an alternative embodiment, the dialysis center 120 administers the PET and generates the regimens. The dialysis center 120 through network 100 sends the regimens to doctor 110. The doctor reviews the regimens and filters them until they arrive in a set of prescriptions for approval or disapproval. The filtration can be carried out again with the patient's entrance either through the 100 network, telephone or personal visit. If the doctor disapproves, the doctor can carry out additional filtering to optimize a new set of prescriptions. Here, the doctor 110 sends the approved prescriptions to the instrument 104 and the patient 102 through the network 100. As an alternative, the doctor 110 stores the approved prescriptions, and instrument 104 on a given day, consult doctor 110 through network 100 to determine what prescription it will administer. As an additional alternative, the doctor 110 sends the approved prescriptions to the dialysis center 120 through the network 100, the dialysis center stores the approved prescriptions and the instrument 104, on a given day consults the dialysis center 120 through the 100 network to determine what prescription you are going to administer.

As described above, it is likely that the dialysis center 120 is in a better position to handle the inventory tracking module or software 18 than the doctor 110. Accordingly, in one embodiment, the dialysis center 120 stores the software. configured to administer the inventory tracking screens of Figures 10 to 13. The dialysis center 120 communicates with the dialysis instrument 104 and the patient 102 through the network 100 to control the inventory of the patient's approved prescriptions.

Referring now to Figure 16A, network 100c illustrates an additional alternative network or communication module 20 (Figure 1). Network 100c also illustrates the patient data collection module 22 of Figure 1. It should be appreciated that the patient data collection principles described in connection with network 100c also apply to networks 100a and 100b. The network 100c includes a central clinic server 118, which can be stored in one of the dialysis centers 120, one of the doctor's offices 110 or in a separate location, such as in an administration facility of the system provider 10. Each of the patients 102a and 102b, doctors 110a and 110b and dialysis centers 120a and 120b communicate with the clinic server 118, through for example Internet 116. The clinic server 118 stores and administers the software associated with either PET, regimen generation, filtering prescription, inventory tracking, trend modification and prescription modules (below) and facilitates communication between patients 102a / 102b, doctors 110a / 110b and healthcare centers dialysis 120a / 120b.

The clinic server 118 in one modality, receives PET data from one of the dialysis centers 120 (referring to any of the centers 120a or 120b) and sends them to the clinic server 118. The UF data points of Figure 3 can be sent to the clinic server 118 either directly from the patient 102 (referring to any of the patients 102a or 102b) or from the dialysis center 120 through the patient 102. The clinic 118 server adjusts to curve 30 (figure 3) to the data points, and generates the regimes and either (i) filters the regimens (possibly with the patient's input) into prescriptions optimized by doctor 110 (referring to any of the doctors 110a or 110b) for approval or disapproval or (ii) send regimens to doctor 110 to filter on optimized prescriptions (possibly with patient input).

In any case, the approved prescriptions may or may not be sent to an associated dialysis center 120. For example, if the associated dialysis center 120 administers the inventory tracking module 18 of the system 10, the dialysis center 120 needs to know the prescriptions to know what solutions and supplies are necessary. Also, if the system 10 is operated so that the dialysis instrument of the patient 104 (referring to any instrument 104a or 104b) consults the dialysis center 120 on a given day for which the prescription is administered, the dialysis center 120 needs to know the prescriptions. Alternatively, the patient's dialysis instrument 104 consults the clinic 118 server daily for which prescription to administer. It is also possible for the clinic server 118 to administer the inventory tracking module 18 of the system 10, in which case the associated dialysis center 120 can be relegated to obtain the PET data.

The clinic server 118 can be a simple server, for example, a national server, which is in a logical geographical boundary because different countries have different groups of dialysis solutions approved. If two or more countries have the same group of approved dialysis solutions and a common language, however, the clinic 118 server can serve two or more countries. The clinic server 118 can be a simple server or have language or concentration links between multiple servers.

Referring now to Figure 16B, the network 100d includes a central clinic server 118, which is housed in or near one of the dialysis centers 120. The dialysis center 120 houses a doctor's office 110 and an area of service to 90 patients, including each, one or more computers 112a to 112d. The patient service area 90 includes a server computer 114, which communicates with the clinic server 118 in a modality through a local area network ("LAN") 92 for the dialysis center 120. The server clinic 118 includes a web server of the clinic that communicates with Internet 116 and LAN 92, a data server of the clinic that communicates with LAN 92, and a database of the clinic that interfaces with with the data server of the clinic.

Each of the patients 102a to 102b communicates with the clinic server 118, for example through the internet 116. The clinic 118 server stores and manages the software associated with any PET, regimen generation, prescription of filtration, inventory tracking, trend modification and prescription modules (below) and facilitates communication between patients 102a / 102b, doctors 110 and dialysis centers 120. Other dialysis centers 120 can communicate with the clinic's server. central base 118 with the internet 116. Any of the systems 100a to 100d can also communicate with a service center of the manufacturer of the APD 94 machine, which may include, for example, a service database, a base server of data and a web server. The manufacturer's service center 94 tracks machine problems, supplies new equipment and the like.

Data Collection Feature The PET 12 module, the rate generation module 14 and the filtration or filtration optimization module 16, produce data that the networks 100 (now referencing additionally to the 100c and 100d networks) use for administer dialysis therapies. In this regard, networks 114 and 118 of system 10 use the results of the analysis that has already been carried out. As seen with network 100c, system 10 also generates real-time daily patient data, which feeds a server 114 (from a center 120) or 118 for monitoring and analysis. These real-time data, together with the inputs of the therapy parameter and the target inputs to the therapy, elaborate the data collection module 22 (figure 1) of the system 10.

Each dialysis machine 104 (referring to either or both of the machines 104a and 104b) includes a receiver 122 as illustrated in Figure 16A. Each receiver 122 is encoded with an address and a personal identification number ("PIN"). The patient is equipped with a blood pressure monitor 124 and a weight scale 126. The blood pressure monitor 124 and the weight scale 126 each are supplied with a transmitter, which sends the patient's blood pressure data. and the patient weight data, respectively, wirelessly to the receiver 122 of the dialysis machine 104.

The address and PIN ensure that the information from the blood pressure monitor 124 and the weight scale 126 reaches the appropriate dialysis machine 104. That is, the machines 104a and 104b and the associated blood pressure monitors 124 and weight scales weight 126 are within the range of each other, the addresses and PINs ensure that the dialysis machine 104a receives the information from the blood pressure monitor 124 and the weight scale 126 associated with the dialysis machine 104a, while the dialysis machine 104b receives information from the blood pressure monitor 124 and the weight scale 126 associated with the dialysis machine 104b. The address and PIN also ensure that the dialysis machines 104 do not receive extraneous data from unwanted sources. That is, if the data from an unwanted source is transmitted in a certain way using the same frequency, data range and receiver communication protocol 122, but the data can not supply the address and / or PIN of the correct device, the receiver 122 will not accept the data.

The wireless link between the blood pressure monitor 124, the weight scale 126 and the dialysis machine 104 allows the devices to be conveniently located with respect to each other in the patient's room or house. That is, they are not tied to each other by cords or cables. Or, blood pressure and weight data are entered manually in the instrument 104. However, the wireless link also ensures that the blood pressure data and weight data, when taken, are automatically transferred to the machine. dialysis 104. It is contemplated that the patient takes their blood pressure and their own weight before (during or directly after) each treatment, to provide a blood pressure and weight data point for each treatment. The data collection module 22 is alternatively configured to have a wired connection between one or more of the blood pressure monitor 124 and the instrument 104 and the scale 126 and the instrument 104.

Another data point that is generated for each treatment is the amount of ultrafiltration ("UF") removed from the patient. The three data points, blood pressure, patient weight and UF removed from each treatment, can be stored in the memory of dialysis machine 104, on the data card and / or sent to remote server 114 or 118. Data points are used to produce performance trends as described below.

Any of, or a combination of the processing and memory associated with any dialysis instrument 104, the doctor (or nurse) 112 computer, the clinic 114 server, the clinic 118 web server or the 94 service center of the manufacturer, may be called a "logical implementer".

Generation of Trends and Alert The analysis and trend statistics module 24 (figure 1) of system 10, as seen in the present invention, calculates the averages of short-term and long-term movement of the daily UF and other patient data that are shown more ahead. The monitoring of the real daily UF measured only produces too much noise due to the residual volume and measurement error of the dialysis instrument 104. The trend regimes of the module or characteristic 24, therefore seek and elaborate a trend of the daily data, as well as data that are averaged over one or more time periods.

Generation of Trends and Alert Using Parameters Multiple of the Patient The trend module 24, in one modality, uses the following equation to form the averages of short-term and long-term movement: UFma (n) = 1 / k * (UF (n) + UF (n-1) + UF ( n-2) ... + UF (nk)). For the average short-term movement, typical values for k may be for example three to fourteen days, such as seven days. For the average long-term movement, typical values for k may be, for example, fifteen or fourteen days such as twenty-eight days.

The difference between the target UF and the actual measured UF is established as follows: AUF = UFobjeje.ivo - UF m a · UF0bjeti is the UF prescribed by the clinic, and UFma is the average daily movement value of the actual daily UF measured (either the value measured daily or two to three days for the average short-term movement). AUF can be either positive or negative. When the absolute value of AU F / O F0bjet¡vo exceeds the alert threshold value previously set by the clinic, system 10 (either at the level of machine 104 or through server 114/118) alerts the patient and to specialist 110 and / or physician 120, which may activate a prescription adjustment or other response, as described below.

The alert threshold value may encompass UF anomalies, so that system 10 does not activate a false alarm or is over-sensitive to daily UF fluctuations, which is inherently significant (eg, due to measurement error and volume residual). The following equation illustrates an example in which system 10 requires a number of days of a certain UF deviation: d (generated alert) = | AU F / U F0bjet¡vo | > X% during Y days.

X% can be pre-adjusted by the clinic or doctor, and a typical value can be 30 to 50%. And it can also be pre-adjusted either by the clinic or doctor, and a typical value can be from three to seven days.

The following equation addresses the possibility that a patient skips dialysis or the patient's FU is consistently much lower than the target FU: ) P% during Q days P% is pre-adjusted by the clinic or doctor, and a typical value can be 150% to 250%. Q can also be pre-adjusted by the clinic or doctor, and a typical value can be two to three days. The above equation calculates a difference between the daily measured UF and the target UF and expresses the difference as a percentage of the target UF to determine an error in the percentage. Subsequently the error rate is accumulated over several days, for example, two to three days (Q). If accumulated errors exceed the threshold value (P%), system 10 will generate UF alerts. The following examples illustrate the previous algorithm: Example 1 : P = 150%, Q = 3 days Day # 1, therapy skipped by the patient, error UF = 100%; Day # 2, therapy skipped by the patient, error UF = 100%; Day # 3, therapy carried out by the patient, error UF = 10%; accumulated UF error = 210% > 150%, then it will generate the alarm.

Example # 2: P = 150%, Q = 3 days Day # 1, therapy skipped by the patient, error UF = 100%; Day # 2, therapy carried out by the patient, error UF = 20%; Day # 3, therapy carried out by the patient, error UF = 10%; accumulated UF error = 130% < 150%, the alarm will not be generated.

Figures 17 to 21 show the trend screens 128, 132, 134, 136 and 138, respectively, which can be displayed for the patient in a screen apparatus 130 of the dialysis instrument 104 and / or on a computer monitor in the doctor 110 or dialysis center 120. The generation of tendencies in any of these places is contemplated, as necessary. The main trend screen 128 of Figure 17 allows the patient, for example, to select to see: (i) pulse and pressure tendencies; (ii) recent therapy statistics; (Ii) UF trends; and (iv) weight trends. The patient can access any of the screens through a contact screen input, through a membrane or other type of connector associated with each selection, or through a button or other selector that allows one of the selections to be signaled , after which the patient presses a "select" button.

When the patient selects the pulse and pressure trend option of the main trend screen 128, the display apparatus 130 displays the pulse and pressure trend screen 132 of FIG. 18. The pulsation is shown (heart rate, line with · '), Systolic pressure (line with A's), and diastolic pressure (line with «' s) during a period of one month in units of mmHg. Selection options on the pulse and pressure trends screen 132 include (i) returning to the main trend screen 128, (ii) observing the weekly pulse, systolic pressure and diastolic pressure trends and (iii) advancing to the next Trend screen 134. The one or more therapies carried out during the trend period, ie therapy number 1 (for example, standard UF) are also shown.

When the patient selects the next trend selection of the pressure and pressure trend screen 132, the display apparatus 130 displays a statistics or trends screen of the recent therapy 134, as shown in Figure 19. Figure 19 shows actual values for the eliminated UF (in milliliters, including total UF and interruption of UF's for day and night exchanges), accumulated retention time (in hours, seconds, including total retention time and retention times for interruption during day and night exchanges), drainage volume (in milliliters, including total volume and interruption for day and night exchanges), and volume of filling (in milliliters, including total volume and interruption volume for day and night exchanges). The trend or statistics screen of the recent therapy 134, as shown in Figure 19, shows, in one modality, statistics of previous therapy. Screen 34 alternatively includes a registration option that enables the patient to see the same information for previous therapies, for example, therapies up to one month before or since the last set of prescriptions has been downloaded. The selection options displayed on the recent trends or therapy statistics screen 134 include (i) return to the main trend screen 128, (ii) return to the previous trend screen 132 and (iii) advance to the next screen of Trends 136.

When the patient selects the next trend selection from the recent therapy trend or statistics screen 134, the display apparatus 130 displays a UF 136 trend screen as seen in figure 20. The UF 136 trend screen shows a target UF line and a UF line measured for a period of one month in units of milliliters. UF trend screen selection options include (i) returning to the main trend screen 128, (ii) weekly search for UF trends, monthly UF trends or even three-month UF trends as long as the data is available, and (iii) advance to the next screen of trends 138. The therapy carried out during the "UF trend period" is also shown.

When the patient selects the next trend selection from the trend screen of the recent UF 136, the display apparatus 130 displays a patient weight trend screen 138 as seen in Figure 21. The weight trend screen of the Patient 138 shows in units of pounds, a line of measured body weight ("BW") over a period of one month. The selection options on the patient weight trend screen 138, include (i) returning to the main trend screen 128 and (ii) advancing to the next screen. The therapy carried out during the BW trend period is also shown.

The alternative trend plots of Figures 22 and 23 show the actual days on the x-axis. These trends can be reserved for the doctor 110 and / or dialysis center 120 or be additionally accessible to the patient, which means that alerts can be generated from the APD 104 device to the doctor and / or doctor or from a server computer to the doctor, doctor and / or patient. The trend graphs of Figures 22 and 23 show the expected UF value or UF objective of the patient based on the latest patient PET results. If the difference between the expected UF PET and the actual UF increases beyond a value that the doctor or doctor determines as significant, the clinic can order a new PET with or without laboratory work. That is, the patient can perform the UF portion of the PET as described in connection with Figures 2 and 3, and bring the drainage volumes to the dialysis center 120. US Patent Application No. 12 / 128,385 , entitled "Dialysis System Having Effluent Sampling and Automatic Peritoneal Equilibrium Test", filed on May 28, 2008, the total contents of which are incorporated herein by reference, describes an automated PET, which results in samples of effluent that the patient can take to the dialysis center 120 so that the samples can be analyzed for the clearance of urea, clearance of creatinine, etc.

The trend graphs of figures 22 and 23 also show that the prescription of therapy was used on that particular day, as shown on the right side of the figures (assuming, for example, that the prescription of therapy Zero is low level UF , the prescription of therapy One is the standard UF and the prescription of therapy Two is UF of high level). As shown in figures 22 and 23, the standard UF prescription is carried out every day, except two days, in which the high-level UF prescription is carried out. In Figure 22, the thirty-day moving average (line with »'s) shows in particular that, in general, the patient's treatment is meeting the goal of UF. In Figure 23, the thirty-day moving average (line with »'s) shows that after approximately October 2, 2006, the patient's treatment began not to meet the goal of UF and was progressively getting worse. In addition, the entire thirty-day trend line for October 2006 has a slope towards less and less UF elimination. An expert doctor here will see the trend potentially due to a loss of the patient's kidney function and either (together with a doctor) ordering a new PET, will provide new prescriptions or put the UF performance of the patient in close observation to see if the trend continues. The clinic / doctor can alternatively prescribe that the high-level UF prescription be carried out more frequently in an attempt to reverse the UF trend that is conducted in a negative way.

As mentioned above, the doctor or doctor probably does not want to be notified when only day, values fall below the lower limit. Therefore UF data does not need to be filtered. The filter considers for example the three daily UF values, the average UF of seven days 'enrollment (line with T's) and the thirty-day enrollment average (line with »' s) in an algorithm to determine whether the patient's prescription needs be modified The filter can also consider what therapies are taking place. For example, an alert notification occurs quickly if the patient administers a high percentage of high-level UF therapies and is still failing to meet the standard therapy UF objectives.

A specific example of an alert algorithm is: the average thirty-day enrollment UF (line with '' s) has failed by 10%, and the actual UF (baseline) is below the lower limit for three of the seven days gone by, while either the standard UF prescription or the high-level UF prescription is carried out. Another specific example of an alert algorithm is: the average UF enrollment thirty days (line with »'s) has fallen by 10%, and the average enrollment UF of seven days (line with V's) has fallen below the lower LCL limit, while either standard UF or high level UF therapies are carried out.

The alert algorithm can also take into account the daily weight and blood pressure data. For example, when the UF deviation, the daily blood pressure and body weight each exceed a respective safety threshold value, an alert is triggered. In a specific example, the system 10 alerts if (i) the UF deviates from the target UF; and (ii) the average body weight ("BW") of short-term movement (eg, three to seven days) is greater than a threshold; and (ii) the short-term average systolic / diastolic blood pressure ("BP") (eg, three to seven days) is greater than a threshold. The BP and BW threshold values are previously adjusted by the clinic 110.

In addition, body weight data alone can trigger an alarm when, for example, the patient is gaining weight in a certain range or gains a certain amount of weight. Here, the system 10 can notify the doctor 110 and / or doctor 120, notifying with a call or email that the patient must request an explanation for the weight gain. If the weight gain is not due to the diet, it may be due to an excessive amount of dextrose in the prescription of the patient, so that another lower dextrose prescription or a set of such prescriptions may be needed. For example, clinic 120 can adjust the target body weight of the patient, and if the measured daily body weight is outside the Xw pounds for the Yw days over a period of seven days, the body weight gain is considered excessive and active. an alarm: ABW = BWm - BWobjective > Xw for Yw days, where BWm is the daily body weight measured, -BWobjet¡vo is the target body weight (adjusted by doctor 110 or clinic 120), Xw is a body weight limit that exceeds the target (adjusted by the doctor 110 or clinic 120), and Yw is the number of days (adjusted by doctor 110 or clinic 120).

Similarly, an increase in blood pressure alone may promote a communication from doctor 110 and / or clinic 120 to obtain an explanation from the patient. The development of a trend of the patient's daily bioimpedance is also contemplated, especially if the detection comes from age. A bioimpedance sensor, for example, may be integrated in a blood pressure cuff (for wired or wireless communication) with the dialysis instrument 104), so that said detection is not inconvenient for the patient. The system 10 uses bioimpedance in a modality to monitor the hydration status of the dialyzed patient, estimating the intra and extra cellular water of the patient. These data help the patient and the clinic select a therapy (for example, high-level UF when the patient is over-hydrated and low-level UF when the patient is dehydrated). Bioimpedance can therefore help control the balance of fluids and blood pressure of the patient.

The clinic is mainly aware of two factors: the effectiveness of the therapy and patient compliance. Patients whose UF is below a target because of they are administering a low level UF therapy too frequently, or they are skipping therapies, they have to be notified in a timely manner to change their behavior. Patients whose UF is below target but who are fully complying and may even be performing high-level UF therapies to obtain their target UF, may need to have their prescription (s) changed in a timely manner. The trends in Figures 22 and 23 provide all of this information to the doctor.

The system 10 knows, therefore, whether the lower than expected UF is due to compliance aspects or potential prescription therapy aspects. In one embodiment, in which the patient chooses to collect the prescription to perform on a given day, the dialysis instrument 104 can be programmed to provide an alert to the patient when the patient is administering the low level UF prescription too much. frequent (low-level UF prescription may be less demanding than the UF prescription) high-level prescription. The programming can be configured to scale the alerts and the patient continues with this behavior, letting the patient know that the dialysis center 120 is notified, and notifying the corresponding to the dialysis center. The instrument 104 can also be programmed to alert the patient, if the patient skips many treatments and notify the dialysis center 120 if the missing treatments continue. Here, the alert and notification can be made regardless of whether the patient collects the prescription to be carried out, or the machine 104 / clinic 120 prescriptions are chosen on a given day.

Figure 24 summarizes the options available to configure simple or complex alert generation logic. The parameters that can be monitored include (in the top row): (i) limit of daily UF deviation, (ii) accumulation limit of UF deviation, (iii) target body weight and (iv) blood pressure limit. The operators of the average logic show that using one or more of (a) daily measured UF, (b) measured daily body weight, and (c) measured daily blood pressure, the upper row limits can be combined in different combinations using Boolean logic "AND" logic "OR" to determine when an alert is sent to the patient, doctor or doctor. The alerts illustrated are based on (i) UF and BW or (ii) UF, BW and BP. However, an alert may be based only on UF.

Referring now to Figure 25, the algorithm or action flow diagram 140 shows an alternative alert sequence of the system 10. When starting in the oval 142, the system 10 collects daily the UF, BP, and BW data in the block 144. In block 146, the deviation analysis is carried out, for example based on the configurations of the doctor / doctor and enrollment averages for UF, BP and BW. In diamond 148, the method or algorithm 140 of system 10 determines whether any of UF, BP, and BW is exceeding the limits. If not, the method or algorithm 140 waits another day, as observed in block 150, and subsequently returns to the collection step in block 144. If one or a combination of limits is exceeded in diamond 148, a Alert the patient, doctor and / or doctor. The deviation and accumulated values are readjusted.

Subsequently, a maintenance or observation period begins in diamond 154, for example, for seven days, to see if the warning condition persists. During this period, it is contemplated that system 10 communicates daily between patient 104, doctor 110 and / or clinic 120 or, regularly in other ways until the low level UF trend is reversed. The clinic can make suggestions during this period, for example to treat the high-level UF prescription or modify the diet to the patient. As described, the dialysis center 120 also receives trend data regarding the patient's weight and blood pressure in addition to the UF trend data. Average blood pressure (MAP) may be the most appropriate value to perform a relative tendency to blood pressure. Physicians evaluate weight and MAP data concurrently during low-level UF periods.

If the alert condition persists for a period, for example seven days, as observed in diamond 154, method 140 and system 10 order a new PET and / or change the patient's prescription, as observed in the block 156. Subsequently, method 140 ends as observed in oval 158.

Case Studies of Patients ^ Patient A started the peritoneal dialysis treatment just two months ago and still has residual renal function ("R R F"). Its target UF is 800 mL / per day. The doctor adjusts the alert to see in the daily UF deviation, in the accumulation of UF deviation and in the target body weight. Here, the deviation limit X was chosen to have 30%, during a Y period equal to four of seven days. A cumulative error of three-day UF deviation was chosen from 150%. The target body weight was selected to be 240 pounds (108.86 kg), with a delta safety limit of + five pounds (2.26 kg) in seven days. The following table is an example of UF, BP and BW of twenty-four hours a day measured over a period of seven days.

Table 5 Measured parameters of the patient In the therapy week shown above for Patient A, only the daily UF on Tuesday falls below the lower limit threshold value of 30%. The cumulative UF deviation of three days does not exceed 150%. The patient's body weight remains below the limit (+ five pounds (2.26kg)) on all but the last two days. Here, system 10 does not generate an alert.

Patient B has been in PD for 2 days. She is very satisfied with her therapy and strictly follows the instructions of the clinic. It does not have any RRF and its daily objective UF is 1.0 L. Here, the doctor 110 and / or clinic 120 adjusts the alert conditions as indicated below. A deviation limit X was chosen to be 20% during a Y period equal to 4 of 7 days. A cumulative error of 3-day UF deviation was chosen to be 150%. The target body weight was selected to be 140 pounds (63.50 kg) with a delta safety limit of + 5 pounds (2.26 kg) in 7 days. The following table is an example of UF, BP and BW of 24 hours measured daily for a period of 7 days.

Table 6 Measured parameters of patient B In the week of therapy shown above for patient B, none of the 24-hour UF values falls below the lower limit threshold value of 20%. The cumulative UF deviation of 3 days does not exceed 150% on any day. The patient's weight never exceeds the threshold value of more than 5 pounds (2.26 kg). Accordingly, the system 10 does not generate a trend alert this week.

Patient C has been in PD for one year. The patient sometimes eats / drinks excessively and skips therapy once in a while. He does not have RRF and his daily objective FU is 1.0 L. Here the doctor 110 and / or clinic 120 adjust the alert conditions as indicated below. A deviation limit X was chosen to be 25% during a Y period equal to 4 of 7 days. A cumulative error of 3-day UF deviation was chosen to be 150%. The target body weight was selected to be 220 pounds (99.7 kg) with a delta safety limit of + 5 pounds (2.26 kg) in 7 days. The following table is an example of your UF, BP and WE of 24 hours measured daily for a period of 7 days.

Table 7 Measured parameters of patient C In the therapy week shown for patient C above, the patient's daily FU fell below a threshold value of 25% on Monday, Thursday, Friday and Saturday, as indicated. The cumulative 3-day UF deviation exceeded the 150% limit after Saturday therapy. The patient also exceeded his weight limit of + 5 pounds (2.26 kg) four times, that is, on Monday, Thursday, Friday and Saturday. The system 10 therefore sends a trend alert after this week.

Trend Generation v Alert Using Control Statistical Process It is also contemplated to use statistical process control ("SPC") to identify unusual and unstable circumstances. Referring now to Figure 26, an example moving average or trend is shown, showing an average UF of 5 days (triangles) and an average UF of the previous 30 days (average baseline). A range is calculated that will be the difference between the lowest and highest UF values during the past 30 days. An upper control limit ("UCL", line with X's through it) for a given day is calculated as: UCL = (the average movement for the given day) + (a constant, for example, 0.577, * the range for the given day) and the lower control limit ("LCL", line with / 's through it) is calculated as LCL (the average of movement of the determined day) - (the constant, for example, 0.577, * the range for a given day).

Figure 26 shows a UF trend created for a patient, for example, from August 2003 to June 2004 using SPC. In December of 2003 and in April of 2004, the average UF of movement of 5 days (triangle) fell below LCL. System 10 should be configured to monitor the 5-day average and alert the patient, physician and / or doctor when the average UF of 5-day movement (triangles) falls below the LCL (or falls below the LCL for a number of days in a row). The software configured to generate the trends can be located on the dialysis instrument 104 or on any of the server computers 114 or 118. In various embodiments, any one or more or all of the patient 102, dialysis center 120 or doctor 110 can access and see the trends. Trend data is generated whether the trend is actually seen or not by either. The alerts are generated automatically in one mode, allowing the system 10 to monitor the patient 102 automatically for the dialysis center 120 and the doctor 110.

Figure 27 shows a second trend for the same patient after the changes to the patient's prescription have been made. Here, the patient's day exchange has been switched from the Nutrineal® dialysate to the Extraneal® dialysate. Figure 27 shows the difference (line with »'s) that a new prescription had in the UF of the patient that started in September 2004, and again in November 2004 when the residual renal function of the patient was decreased.

The statistical process control alert algorithm can also take into account body weight ("B") and / or blood pressure ("BP"). If the UF has a normal distribution, it has an average value of μ and standard deviation of s calculated based on time and population, and where C is an empirically determined constant. In the majority of the processes that are controlled using the Statistical Process Control (SPC), at each point of time, measurements of multiple observations are made (for example, the ambient temperature is measured several times at 8:00 AM), however, in one embodiment of the system 10, the SPC only performs one measurement at each time point, for example, a UF measurement, a pressure reading and weight per day. Subsequently system 10 can alert if: (i) the average UF of short-term movement (3 to 7 days) is outside the upper control limit (UCLUF = UFobjet¡vo + Co) or lower control limit (LCLUF = UF0bjet) Vo- Co); or (ii) the average body weight of short-term movement (3 to 7 days) > threshold value BW; and / or (iii) short-term average systolic / diastolic BP (3 to 7 days) > BP threshold value.

Figure 27 shows that the SPC trend graphs can also display the expected UF value (line with A's) for the patient based on their latest PET results. The average 30-day line shows that the actual UF, while being slightly behind the expected UF (which will be the expected one for an average of 30 days) is eventually aligned by itself with the expected UF results. Here, the patient is not performing a sub-performance, he has the ability to meet the goal. However, the patient may be losing RRF, which means that the patient's prescription needs to be more aggressive for UF because the patient has a lower ability to increase waste by itself and excess water. On the other hand, if the difference between the expected UF and the actual UF increases beyond a value that the doctor / physician determines to be significant, for example, under LCL for one or more days, the clinic / doctor can order a new one. PET as described above.

Repetition v Prescription Modification System 10 also includes a prescription repetition and modification feature 26 shown and described above with reference to Figure 1. Referring now to Figure 28, the prescription adjustment and repetition feature or module 26 is Illustrates in more detail. The prescription repetition and adjustment module or feature 26, depends on, and is inferred from, other features of the system 10, such as the enhanced PET feature 12, the regime generation characteristic 14, the filtering prescription feature 16, and the trend generation and warning feature 24. As seen in Figure 28, one aspect of the characteristic or module of repetition and adjustment of prescription 26 is the selection of one of the approved prescriptions for treatment.

Referring now to Figure 29, a screen 160 of the screen apparatus 130 of the dialysis machine 104, illustrates a patient selection screen that allows the patient to select one of the approved prescriptions (standard, high level and low UF). level) for the treatment of the day. The type of input can be through the membrane keys, or here, through a contact screen, for which areas 162, 164 and 166 have been mapped in memory as standard UF prescription selections, UF prescription high level and low level UF prescription, respectively. The system 10 in the illustrated mode allows the patient to select a prescription for each day of treatment. For example, if the patient has consumed more fluids than usual on a given day, the patient can administer the high-level UF prescription. If the patient has worked, being in the sun, or for any reason a large amount has elapsed during the day, the patient may choose to administer the low level UF prescription.

If the patient, for example, observing the previous 134 and 136 therapy trend screens, observes a drop in UF administration of the standard UF prescription, the patient is enabled to choose to administer the high-level UF prescription for some time. days, to observe how the patient reacts to the prescription change.

In a remarkable way, it will increase the daily UF. However, it should also be appreciated that the patient, doctor or doctor should check to see if the actual increased UF meets the expected UF increased due to the use of the high level UF prescription. If the patient is underperforming for both prescriptions, it may be time for a new PET and possibly a new set of prescriptions.

By allowing the patient to adjust his therapy as described above, he is likely to perform it only when the doctor or doctor has a comfort level with the patient, so that the patient agrees in terms of lifestyle and adherence to the treatment. Also, the doctor / practitioner may wish to ensure that the patient has sufficient experience with the treatment and the dialysis instrument 104, in order to have the ability to accurately calibrate when a high-level UF treatment is needed, versus low-level UF versus Standard UF. Even if the patient is making prescription decisions in this modality, the data for trend as shown above is being sent to the dialysis center 120 and / or doctor 110, so that if the patient is making bad decisions, as for what prescriptions to carry out, the dialysis center 120 and / or doctor 110 can detect the situation in time in order to correct it. For example, the system 10 enables the dialysis center 120 and / or doctor 110 to eliminate the prescriptions of a possible selection, or adjust the dialysis instrument 104, so that it automatically selects a set of prescriptions either on the machine 104 or on server computer 114 or 118.

It is considered, due to the importance of a dialysis treatment, that the majority of people will be responsible and that a conscious patient in full use of their faculties will have the best capacity to calibrate when they need a more aggressive or less aggressive prescription, knowing that even the least aggressive prescriptions have been approved and will eliminate a certain amount of UF. It is expected to provide more than three prescriptions. For example, the patient may have two high-level UF prescriptions, one requiring longer night therapy and the other requiring a higher level of dextrose. Assuming that the patient knows that he needs to administer a high-level UF prescription after a relatively large day of fluid intake, the patient can choose the high-level UF prescription for the longest night therapy, knowing that he has gained weight of the day and It is better to stay out of a high-level caloric intake of the higher-level dextrose prescription. The system 10 attempts to accommodate the patient's lifestyle, while ensuring that the appropriate therapy is carried out, while also collecting the data of the therapy over time to establish a complete patient history that allows the specialist to detect in relatively fast and accurate physiological changes of the patient.

In another embodiment, the dialysis instrument 104 selects which prescription the patient should perform based on the patient's daily body weight and possibly the patient's blood pressure. The patient is weighed also, transmits a weight signal, for example, wirelessly to the dialysis instrument 104, which uses the weight signal to determine how much UF the patient has accumulated and therefore what prescription to carry out. In one embodiment, the patient is also weighed just before the last nightly filling or just before the last half-day filling to establish a localized "dry weight". The patient is then weighed at night, just before the last filling drain to establish a localized "wet weight". The difference between the localized "wet weight" and the localized "dry weight" determines an amount of UF. The amount of UF is adjusted in either a low low level UF, a standard UF range and a high level UF range. Subsequently the dialysis instrument 104 takes to perform a low level UF prescription, standard UF prescription or corresponding high level UF prescription. Alternatively, the dialysis instrument 104 provides alternative prescriptions for a particular range, for example, two high-level UF prescriptions, allowing the patient to take one of the two high-level UF prescriptions. As described above, the dialysis instrument 104 is configured in one embodiment to read the identifiers of the bag to ensure that the patient is connected to the appropriate dialysate (s) and the appropriate amount (s) of dialysate (s).

In a further alternative embodiment, the doctor 110 or dialysis center 120 chooses or approves previously the prescriptions that will be carried out on a given day, so that the patient does not have the capacity to administer a different prescription. Here, the fill, hold and / or drain times can be pre-set, and the dialysis instrument 104 can also be configured to read the bag identifiers to ensure that the patient connects the proper dialysate (s) and the amount ( s) adequate dialysate (s).

It is additionally contemplated to allow the patient to have admission to where the prescriptions are carried out, but where the doctor 110 or dialysis center 120 finally approves a prescription selection or a selection plan before the prescriptions are downloaded in the dialysis instrument 104. For example, it is contemplated that the dialysis center 120 sends a self-generated email to the patient 102, for example, every month a week, before the start of the next month. The email includes a calendar, each day of the calendar shows all the available prescriptions, for example, (i) UF low level, (ii) UFIowDEX half level, (ii) UFhighDEX half level, (iv) UFIowDEX high level y ( v) UFhighDEX high level. The patient clicks on one of the prescriptions for each day and sends the completed calendar for approval to clinic 120. For example, the patient may choose to administer one of the high-level UF prescriptions on the weekends, and one of the prescriptions means or standard during the week. Possibly the patient attends physical demanding job classes after work on Mondays and Wednesdays and selects the low level UF prescription for those days.

It is considered to allow the patient to type notes in the days, to explain why a particular prescription has been proposed. For example, the patient can select the low level UF prescription and the type of "cycling class" on that calendar day. Or the patient can select the high-level UFhighDEX prescription and type "birthday party, until dawn the next day" on said calendar day.

When the clinic receives the proposed, completed patient calendar, the clinic can either approve the proposed calendar, call or e-mail the patient with questions about why one or more prescriptions were chosen for a particular day, send the calendar to the doctor's office 110 if the clinic is concerned or has questions regarding the proposed calendar, or modify the selections in the calendar and send the modified calendar back to the patient. The clinic can review the patient's trend data when evaluating the proposed prescription schedule. For example, if the patient has gained weight and has selected the standard FUs with high dextrose content for many or all of the days of the month, the clinic can make a call or send an email to the patient and suggest changing to the UF prescription standard of low dextrose content in an attempt to control the patient's weight gain.

Eventually, the clinic and the patient reach a consensus. The doctor may or may not need to be consulted. It is expected that the patient's calendars search similarly from month to month and may change naturally based on a season of the year, vacations and holidays. When a more radical change is presented, for example, the patient intends to initiate vigorous physical work or a training routine and wishes to introduce more days of low level UF, the clinic can seek the approval of the doctor.

In one embodiment, the dialysis instrument 104 confirms that the patient wishes to carry out a non-standard treatment on a particular day. The dialysis instrument 104 also allows the patient to switch to a standard therapy if the patient so desires. For example, if the patient has Mondays and Wednesdays approved for a low level UF prescription, because the patient expects to have vigorous physical work those days, but the patient skips a day of physical work, the patient can choose to take rather a standard UF prescription. Or, if the patient has a schedule for administering a high-level UF prescription because he is supposed to attend a party on a given day but miss the party, the patient may instead perform a standard UF prescription.

The dialysis instrument 104 may also be configured to provide the patient with a limited amount of prescription changes from a standard UF prescription to a low level or high level UF prescription. For example, if the patient decides to do physical work on Thursday instead of Wednesday, the patient can change the prescription from standard UF to low level UF on Thursday. The system 10 may be configured to allow a change of prescription from standard to non-standard per week.

In another example, the dialysis instrument 104 allows the patient to increase UF elimination at any time, that is, by changing the low level UF prescription to a standard or high level UF prescription, or changing from a standard UF prescription to a standard UF prescription. UF prescription at high level at any time. If the patient chooses this option a certain number of times during the month, the dialysis instrument 104 may be configured to send an alert to the doctor 110 or clinic 120.

The approved calendar in one modality is integrated with the inventory tracking feature 18. The approved calendar says the inventory tracking feature 18 that is necessary for the next supply cycle, which can be a month-to-month cycle. If the patient can plan and gain approval for multiple months, the supply cycle can be for multiple months. In any case, the patient can be provided with an extra solution if needed, to allow changes in the planned descriptions.

In an additional alternative modality, the patient and the clinic and / or doctor agree that for each week the patient will carry out a certain number of standard, low-level and high-level prescriptions, for example, five standard, one of low level and a high level. Subsequently the patient chooses which days during the week he carries out the various prescriptions. The weekly fee does not have to include any low level UF or high level UF fees. The patient can have seven standard UF quotas with four standard prescriptions with low dextrose content and three standard prescriptions with high dextrose content, for example. Here also, the dialysis instrument 104 may be configured to leave the patient's change prescriptions in certain cases as described above.

In a still further alternative embodiment, the dialysis instrument 104 or one of the server computers 114 or 118, takes one of the prescriptions approved for the patient for each therapy. The intake may be based on any of the above trend data and / or based on a series of questions answered by the patient such as: (i) Was your fluid intake this day low, moderate, average, high or very high? (ii) Was your food intake this day low, moderate, average, high or very high? (iii) Did your carbohydrate intake this day be low, moderate, average, high or very high? (iv) Was your sugar intake this day low, moderate, average, high or very high? (v) Did your activity level this day be low, moderate, average, high or very high? The system 10 subsequently takes one of the prescriptions approved for the patient. The inventory management for this mode can be based on the average uses in the last X number of supply cycles. In any of the above regimens, the dialysis instrument 104 may also read the bag identifiers to ensure that the patient connects the appropriate dialysate (s) and the proper amount (s) of the dialysate (s).

As shown in Figure 28, the selected daily prescriptions are fed into a switching mechanism of the repetition and prescription modification feature 26. The switching mechanism is activated when the alert generation algorithm applied to characteristic 24, computes an error that is greater than the threshold value (s) of the alert generation algorithm applied. As seen in Fig. 28, when the applied warning generation algorithm of characteristic 24 computes an error that is not greater than the threshold value, characteristic 26 maintains the set of current prescriptions and any prescription repetition regimen. that is being used. Therefore, the switching mechanism does not switch to a new prescription or set of prescriptions.

When a prescription is used for a treatment, the prescription is carried with an anticipated FU, which is generated through the regimen generation characteristic 14 and is selected by the filtering prescription feature 16. The anticipated FU is also carried performed through the deviation of the patient's regimen as observed in the adder 64 of the transfer function of Fig. 28.

The actual UF data are obtained from averages, short-term movement and long-term as described above in relation to the characteristic of generating warning trends 24, which in turn are developed from the measured UF data generated in the dialysis instrument 104. The function of the area of actual UF values of the patient's transport characteristics are as described in the present invention, but also encompass environmental factors, such as deviation of the regimen by the patient. The actual UF values are subtracted from the anticipated UF values in the difference generator 66a and fed into the algorithm for generation of alerts in the diamond 24. The actual UF values are also fed into the generator of different 66b, which are used for adjust the target UF values used to generate the regimes in connection with characteristic 14. Other objective values include the removal of target urea, the removal of target creatinine and the target glucose uptake as described above.

As seen in the diamond 24, once the system 10 determines an alarm condition, the system 10 activates the prescription adjustment switching mechanism. This does not necessarily mean that the patient's prescriptions will be adjusted. Doctor 110 finally makes a call based on UF data, daily weight of the patient, daily blood pressure or estimated dry weight using a bioimpedance sensor. When a prescription adjustment appears as a necessary, the system 10 through a communication model 20, communicates with the patient, for example, through wireless communication between the APD system to the modem through a router. Based on the data received, the nephrologist 110 in the switching mechanism 26 can make the following decisions: (i) continue with the current prescriptions and arrive at a visit to the office as previously planned; (ii) continue with the current prescriptions but visit the office as soon as possible for a possible prescription adjustment; (iii) switch to a different routine using the current prescriptions, visit the office soon, for example, in the next two weeks, receive trend data in a new routine; (iv) alert the patient that he or she is not complying with the treatment and maintain the current prescription (s); (v) alert the patient that he or she is carrying out a low-level UF prescription (s) very frequently and maintain the current prescription (s); (vi) continue current therapy and monitor, but decrease the UF goal to A and decrease the UF to B limit; and (vii) carry out a new APD PET to evaluate the change of PD membrane transport characteristics and supply the center with updated therapy suggestions based on this PET.

If the patient fully agrees and the low level UF is as a result of changes in transport characteristics as verified by the new PET, the doctor 110 can order a new one or generate a new prescription, or generate it , including a change in one or more standard UF prescriptions. In doing so, the regime generation module 14 and the filtering prescription module 16 is again used to develop the new prescription (s). The doctor agrees with the new prescriptions and the switching mechanism 26, changes the new prescription (s) as shown in figure 28.

It should be appreciated that those skilled in the art will appreciate various changes and modifications to the preferred embodiments in the present invention as described herein. Said changes and modifications can be made without departing from the spirit and scope of the subject matter of the present invention, and without diminishing its projected advantages. Accordingly, it is intended that said changes and modifications be covered by the appended claims.

Claims

1. A peritoneal dialysis system comprising: accommodation; at least one pump carried by the housing and configured to fill a patient with fresh dialysate and drain the spent dialysate from the patient; Y a logic implementor configured in an ultrafiltration evaluation sequence ("UF") for: (i) causing at least one pump to pump fresh dialysate to the patient and drain the patient's spent dialysate after a first retention time; (ii) determining, as a part of the first dialysate spent, a first quantity of FU removed from the patient during the first retention time; (ii) causing at least one pump to pump the fresh dialysate to the patient, and drain the patient's spent dialysate after a second, different, and (iv) As a part of the second dialysate spent, a second amount of UF removed from the patient from the second retention time, different.

2. The peritoneal dialysis system as described in claim 1, characterized in that the logic implementor is additionally configured to (v) cause at least one pump to pump fresh dialysate to the patient and drain the patient's spent dialysate after the third time of residence, different and (vi) determine, as a part of the third dialysate spent, a third amount of UF removed from the patient from the third residence time, different.

3. The peritoneal dialysis system as described in claim 2, characterized in that the logic implementor is further configured to (vii) cause at least one pump to pump fresh dialysate to the patient and drain the patient's spent dialysate after the fourth time of residence, different and (vi) determine, as a part of the fourth dialysis spent, a third amount of UF removed from the patient from the third residence time, different.

4. The peritoneal dialysis system as described in claim 1, characterized in that the first and second residence times are different from: nominal residence time of 30 minutes, nominal residence time of 60 minutes, nominal residence time of 120 minutes and nominal residence time of 240 minutes.

5. The peritoneal dialysis system as described in claim 1, characterized in that the first and second residence times are taken from one of: (i) a time from the end of a pump to the patient to the beginning of patient drainage; and (ii) a time from the end of the pumping of the patient to the end of the patient's drainage.

6. The peritoneal dialysis system as described in claim 1, characterized in that it includes a data transfer apparatus configured to operate with the logic implementor for transferring the first and second quantities of UF eliminated from the first and second residence time to a location remote

7. The peritoneal dialysis system as described in claim 6, characterized in that the data transfer apparatus is of a type selected from the group, consisting of: (i) a data card; and (ii) a data network.

8. The peritoneal dialysis system as described in claim 1, characterized in that the logic implementor is further configured to record the real first and second residence times, and to compare the first and second real times with the first and second quantities UF respective.

9. The peritoneal dialysis system as described in claim 1, characterized in that the logical implementor is a first logical implementor, and which includes a second logical implementor, the logical first calculating a sufficient number of UF quantities for a different residence time enough for the second logical implementor to adjust a curve to the UF quantities.

10. The peritoneal dialysis system as described in claim 9, characterized in that the second logic implementor is further configured to determine at least one of a hydraulic / LPA coefficient and a fluid absorption coefficient that uses the curve and uses the minus a coefficient to develop at least one therapy regimen for the patient.

11. The peritoneal dialysis system as described in claim 10, characterized in that the at least one additionally developed therapy regimen utilizes at least one of: (i) chemical analysis of the patient's blood; (ii) chemical analysis of the patient's spent dialysate; and (iii) a kinetic model.

12. An ultrafiltration ("UF") evaluation method comprising: determining a quantity of FU removed from the patient during a first residence time; determine a quantity of UF removed from the patient during a second residence time, different; determine a quantity of UF removed from the patient during a third residence time, different; Y adjust a curve to the UF elimination amounts for the first, second and third residence times.

13. The UF evaluation method as described in claim 12, characterized in that it includes using the curve to determine an optimal residence time of a residence time range.

14. The UF evaluation method as described in claim 12, characterized in that it includes determining UF removal amounts for five residence times and adjusting the curve to the five removal amounts.

15. The UF evaluation method as described in claim 12, characterized in that the adjustment of the curve to the UF elimination amounts includes the use of the first, second and third real residence times as opposed to the first, second and third time of residence prescribed.

16. The UF evaluation method as described in claim 12, characterized in that the determination steps are carried out using the patient's automatic peritoneal dialysis machine and the adjustment step is carried out through a different apparatus.

17. The UF evaluation method as described in claim 12, characterized in that the determination of the UF amounts includes subtracting a volume of fresh dialysate delivered to the patient from a volume of spent dialysate removed from the patient during each residence time.

18. A method of generating peritoneal dialysis therapy using the curve determined as described in claim 12, to generate at least one regimen of peritoneal dialysis therapy.

19. The method of generating peritoneal dialysis therapy as described in claim 18, characterized in that it includes at least one of (i) analyzing the blood of the patient; (ii) analyzing the spent dialysate of the patient and (iii) using a kinetic model in addition to using the curve as described in claim 12 to generate the at least one peritoneal dialysis regimen.

20. The method of generating peritoneal dialysis therapy as described in claim 18, characterized in that it includes determining at least one of (i) a hydraulic LPA coefficient of the patient and (ii) a fluid absorption coefficient of the patient from the curve and using the at least one coefficient to generate the at least one peritoneal dialysis regimen.